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PubMed2004

Nadroparine calcium or enoxaparine in acute coronary syndrome patients suffering renal insufficiency: The nadroparin versus enoxaparin (NaVe) study design.

In the general population, mild renal impairment is associated with increases risk for coronary artery disease and stroke, suggesting that cardiovascular disease begins to develop early in the natural history of renal dysfunction. Patients with renal failure are known to be at increased risk of death following acute myocardial infarction or congestive heart failure.In such sense, anticoagulation in addition to antiplatelet inhibitor drugs became the standard of care, particularly, among high risk unstable angina patients associated with a scarce side effects.The Nadroparin calcium Versus Enoxaparin (NaVe) Study will evaluate in a head to head basis the anti Xa activity reached by nadroparine or enoxaparine, both low molecular weight heparins, in patients at high risk for ischemic episodes, and renal insufficiency to eventually be undergone to angiographic diagnosis studies, and in consequence proposing the best anticoagulant strategies for these patients before being invasively treated.Patients will be randomly assigned to one of the two groups: Group 1: thirty patients will be given with subcutaneous enoxaparine injections into the abdominal wall in a dose of 0,85 mg/kg every 12 hours for a maximum of 48 hours. A saline infusion dose will be given in between. Total number of injections: 6. Group 2:Thirty patients will be receiving subcutaneous injections into the abdominal wall in a doses of 30% less in relationship with his / her body weight every 8 hours for a maximum of 48 hours.In order to achieve the goal of the study, the antiXa activity will be measure using venous blood samples taken as follows: Group 1:*Within 3rd and 4 hour of the second doses of HBPM for enoxaparine.*Within 11 th and 12 th hour next to fourth doses of enoxaparine. Group 2: *Within 3rd and 4 th hour next to 3rd doses of HBPM for the nadroparine.*Within 7th and 8th hour next to 4th doses HBPM for the nadroparine.The primary end point is to analyze during the in-hospital stay phase the stability of the anti Xa activity within the therapeutic ranges which will be estimated between 0.5 to 1.0 IU during the first 48 hours.

Journal Article↗

PubMed1997

Nadroparin calcium. A review of its pharmacology and clinical use in the prevention and treatment of thromboembolic disorders.

Nadroparin (nadroparin calcium) is a low molecular weight heparin with a mean molecular weight of 4.5 kD. Compared with unfractionated heparin (UFH), nadroparin has a greater ratio of anti-factor Xa to anti-factor Ha activity, greater bioavailability and a longer duration of action, allowing it to be administered by subcutaneous injection for prophylaxis or treatment of thromboembolic disorders. In clinical trials conducted in older patients (mean age usually > 60 years), nadroparin was at least as effective as UFH in preventing deep vein thrombosis (DVT) and pulmonary embolism after major general or orthopaedic surgery, and in bedridden medical patients. Nadroparin was also at least as effective as dalteparin or oral acenocoumarol in preventing thromboembolic events following general and orthopaedic surgery, respectively. When used for treatment of established DVT, nadroparin was at least as effective as intravenous UFH. Subcutaneous nadroparin, at dosages similar to those used for the treatment of DVT, produced promising results in older patients with pulmonary embolism, acute ischaemic stroke or unstable angina. In 1 study, 75% of nadroparin-treated patients were able to complete their treatment at home and 36% did not require admission to hospital; the potential pharmacoeconomic implications of these results deserve further evaluation. Overall treatment costs (drug acquisition and monitoring costs) were similar for nadroparin and UFH in a French study, but nadroparin was associated with significantly less nursing time spent on treatment delivery. Nadroparin is well tolerated by older patients. The most frequently reported adverse events in a large (n approximately 4500) placebo-controlled study in general surgical patients were wound and injection site haematoma (11.8 and 10.2%, respectively, vs approximately 6.5% for placebo). When used as prophylaxis, no significant differences in bleeding complications were noted between nadroparin and UFH or acenocoumarol recipients. Prophylactic nadroparin was associated with significantly fewer withdrawals because of adverse events than UFH in elderly bedridden medical patients. When used as treatment for DVT, nadroparin was generally associated with lower occurrences of major bleeding than intravenous UFH (0.5 to 2.3% vs 2 to 5%); however, trials were not large enough to demonstrate any significant differences between the 2 agents. Similarly, the incidence of thrombocytopenia was slightly, but generally not significantly, lower in nadroparin (< 1%) than in UFH (< or = 3.5%) recipients. Thus, nadroparin should be considered an effective and well tolerated alternative to UFH for prophylaxis and treatment of DVT in older patients, with the advantage of more convenient administration and decreased monitoring requirements.

Absorption↗

PubMed2000

Local delivery of nadroparin via hydrogel-coated angioplasty balloon: effect on platelet deposition and smooth muscle cell proliferation--an experimental study.

PURPOSE: To assess the feasibility of intravascular delivery of nadroparin, a low-molecular-weight heparin, via hydrogel-coated angioplasty balloons, and the effects of nadroparin delivered in this manner on platelet deposition and smooth muscle cell (SMC) proliferation. MATERIALS AND METHODS: Tritiated nadroparin was used to determine the nadroparin-carrying capacity of the hydrogel-coating, kinetics of release from the balloons, and, in four pigs, delivery of the nadroparin to the iliac arterial wall. Platelet deposition in nadroparin-treated iliac arteries versus contralateral iliac arteries dilated with saline-loaded, hydrogel-coated balloons was quantified in seven pigs using 111Indium-labeled platelets. Smooth muscle cell proliferation in nadroparin and saline-treated iliac arteries in 10 pigs was evaluated 7 days after angioplasty with use of proliferating cell nuclear antigen. RESULTS: Approximately 98 international units of nadroparin were delivered by the hydrogel-coated balloon, the majority to the angioplasty site and distal vessel. There was a trend toward decreased platelet deposition in nadroparin-treated arteries, but statistical significance was not achieved (P = .1563). Medial SMC proliferation was decreased in the nadroparin-treated arteries in nine of 10 pigs (P = .0137). CONCLUSIONS: Hydrogel-coated balloons may be used to deliver nadroparin to the arterial wall, with measurable levels of the drug delivered to the site of angioplasty, and with resultant decrease in SMC proliferation.

Angioplasty, Balloon↗

PubMed2000

Local delivery of nadroparin for the prevention of neointimal hyperplasia following stent implantation: results of the IMPRESS trial. A multicentre, randomized, clinical, angiographic and intravascular ultrasound study.

BACKGROUND: We hypothesized that intramural delivery of nadroparin, a low molecular weight heparin, would prevent in-stent restenosis by inhibiting neointimal hyperplasia in an angioplasty model free of arterial remodelling. METHODS AND RESULTS: In a prospective randomized multicentre trial, 250 patients submitted to balloon angioplasty followed by stent implantation were randomized into control group (no local drug delivery) or intramural delivery of nadroparin (2 ml of 2500 anti-Xa-units/ml with a microporous catheter). An ancillary intravascular ultrasound substudy was performed to supplement angiographic data with specific measurements of in-stent neointimal hyperplasia. The primary end-point was the late loss in minimal luminal diameter on the 6 month follow-up angiogram. Secondary end-points included feasibility and safety of local nadroparin delivery, and major adverse cardiac events at 8 weeks and 6 months follow-up. Local delivery of nadroparin was successful in 124 patients (99.2% success rate) and was not associated with an increase in stent thrombosis, coronary artery dissection, side branch occlusion, distal embolization or abrupt arterial closure. At angiographic follow-up, the late loss in lumen diameter was 0.84 +/- 0.62 mm in the control group compared to 0.88 +/- 0.63 mm in the nadroparin group (P=0.56). Angiographic restenosis rate (defined as a >50% diameter stenosis) did not differ in the control group (20%) compared to the nadroparin group (24%). The average area of neointimal tissue within the stent was 2.86 +/- 0.64 mm(2) vs 2.90 +/- 0.53 mm(2) (P=0.57), control vs nadroparin groups. There was no difference in major adverse cardiac events at any time (88.8% vs 89.6% event free survival at 6 months, control vs nadroparin). CONCLUSION: Intramural delivery of nadroparin with a microporous catheter after stent deployment was feasible and safe but had no effect in reducing restenosis or the occurrence of major adverse clinical events over 6 months.

Adult↗

PubMed2005

[Comparison of the antithrombotlic effect and safety between intravenous nadroparin and unfractionated heparin in patients undergoing percutaneous coronary intervention].

OBJECTIVE: The study was designed to compare the antithrombotic property and safety between nadroparin and unfractionated heparin during percutaneous coronary intervention (PCI). METHODS: A prospective, single blind, randomized study was performed. A total of 98 patients (aged 65.1 +/- 8.6 years, female, 28.6%, diabetes, 7.1%) undergoing selective PCI were randomized to be administered intravenously either nadroparin (0.075 ml/10 kg) or unfractionated heparin (100U/kg) for procedural anticoagulation, in whom stable angina was 42.9%, unstable angina, 27.6%, myocardial infarction, 29.6%, two or three-vessel disease, 23.5%, stent, 100%. Blood samples for anti-Xa level were assayed in the first 22 patients of the nadroparin group before and after administration at the following intervals: 8 min, 1 h, 2 h and 4 h. Bleeding complications were classified according to Thrombolysis In Myocardial Infarction (TIMI) criteria. The bleeding index (change in hemoglobin) was calculated. All patients were monitored for adverse clinical events (i.e. death, myocardial infarction, need for revascularization) during the period of 30 days after PCI. RESULTS: (1) There were no significant differences in baseline characteristics between the two randomized groups. (2) Plasma anti-Xa activities were 0.10 +/- 0.00 IU/ml at the time just before the administration of nadroparin, 1.89 +/- 0.24 IU/ml, 0.96 +/- 0.24 IU/ml, 0.47 +/- 0.13 IU/ml, and 0.30 +/- 0.12 IU/ml at the time of 8 min, 1 h, 2 h and 4 h after the use of nadroparin (and the rate of > 0.5 IU/ml were 100%, 100%, 45% and 9% patients), respectively. (3) There were no significant differences in the mean bleeding index, post-PCI hemoglobin and hematocrit between nadroparin and unfractionated heparin group [(1.16 +/- 5.80) g/L vs (0.90 +/- 6.50) g/L, P = 0.858; (129.5 +/- 13.6) g/L vs (125.5 +/- 14.9) g/L, P = 0.175; (39.0 +/- 3.9)% vs (37.9 +/- 4.6)%, P = 0.205]. (4) None of the patients in two randomized groups were observed hemorrhagic events, which including TIMI major or minor bleeding complications, gross or microscopic hematuria, melena, positive stool occult blood. There were no blood transfusions and no hematoma at the vascular access site in either of the group. (5) No death, no recurrent angina pectoris, and no urgent revascularization occurred within 30 days in both groups. One patient in nadroparin group was observed "no reflow" phenomenon that was accompanied with an elevated ST segment and a risen serum level of cTnI. This patient was diagnosed as non-Q-wave myocardial infarction. Though no myocardial infarction was found in unfractionated heparin group, there was no significant difference in the rate of myocardial infarction between the two groups of the study (P = 0.970). CONCLUSIONS: The administration of nadroparin before PCI seems effective and safe. Compared with unfractionated heparin, nadroparin was associated with neither an excess of bleeding nor an increase of clinical complications in this study.

Adult↗

PubMed1995

Comparison of the pharmacokinetic profiles of three low molecular mass heparins--dalteparin, enoxaparin and nadroparin--administered subcutaneously in healthy volunteers (doses for prevention of thromboembolism).

The present trial was designed to comparatively investigate the pharmacokinetic profile and evaluate the apparent bioavailability pattern of three already marketed low molecular mass heparins (LMMHs): dalteparin (Fragmin), nadroparin (Fraxiparin), and enoxaparin (Lovenox) given by subcutaneous route. The study was carried out in 20 healthy young volunteers given, according to a cross over design, a single subcutaneous injection of the doses recommended for the prophylaxis of deep vein thrombosis (commercial preparations, prefilled syringes): dalteparin 2,500 IU (= 2,500 IU anti-Xa), nadroparin 7,500 ICU (= 3,075 IU anti-Xa), enoxaparin 20 mg (= 2,000 IU anti-Xa) and enoxaparin 40 mg (= 4,000 IU anti-Xa). Of the markers used, activated partial thromboplastin time (APTT), thrombin clotting time (TCT), Heptest, anti-thrombin (aIIa) activity and anti-Xa (aXa) activity, the most pertinent parameter (from a biodynamic viewpoint) is plasma aXa activity. We demonstrated that dalteparin, nadroparin and enoxaparin exhibit statistically significantly different pharmacokinetic and overall disposition patterns. Normalized to the same injected dose (1,000 IU aXa), the relative actual amount of plasma anti-Xa activity generated by enoxaparin is 1.48 times greater (p < 0.001) than that of nadroparin and 2.28 times greater (p < 0.001) than that of dalteparin while the plasma amount induced by nadroparin is 1.54 times greater (p < 0.001) than that of dalteparin. The apparent total body clearance of enoxaparin doses (CL/F = 16.7 +/- 5.5 and 13.8 +/- 3.2 ml/min) is significantly smaller than those of nadroparin (CL/F = 21.4 +/- 7.0 ml/min; p < 0.01) and dalteparin (CL/F = 33.3 +/- 11.8 ml/min; p < 0.001) while dalteparin apparent clearance is about 1.5-fold greater (p < 0.001) than that of nadroparin. These LMMHs also differ by their renal excretion pattern: more fragments exhibiting an anti-Xa activity are recovered in urine following enoxaparin doses (6.4 and 8.7% of the dose, respectively) than following nadroparin (3.9%) and dalteparin (3.4%) injection. These differences in the disposition profiles explain why the apparent elimination half life t1/2 values of the LMMHs compared here are different: dalteparin: 2.8 h; nadroparin: 3.7 h; and enoxaparin: 4.1 h. Whether or not these differences may contribute to explain the different safety/efficacy balance of each of these antithrombotic medications remains to be discussed and needs further studies.

Adolescent↗

PubMed2006

A randomized study comparing the efficacy and safety of nadroparin 2850 IU (0.3 mL) vs. enoxaparin 4000 IU (40 mg) in the prevention of venous thromboembolism after colorectal surgery for cancer.

BACKGROUND: The optimal thromboprophylactic dosage regimen of low-molecular-weight heparins in high-risk general surgery remains debatable. OBJECTIVES: We performed a randomized, double-blind study to compare the efficacy and safety of nadroparin 2850 IU (0.3 mL) and enoxaparin 4000 IU (40 mg) in the prevention of venous thromboembolism (VTE) after colorectal surgery for cancer. PATIENTS AND METHODS: Patients undergoing resection of colorectal adenocarcinoma were randomized to receive once daily either 2850 IU nadroparin or 4000 IU enoxaparin s.c. for 9 +/- 2 days. The primary efficacy outcome was the composite of deep vein thrombosis (DVT) detected by bilateral venography or documented symptomatic DVT or pulmonary embolism up to day 12. The main safety outcome was major bleeding. A blinded independent committee adjudicated all outcomes. RESULTS: Out of 1288 patients analyzed, efficacy was evaluable in 950 (73.8%) patients. The VTE rate was 15.9% (74/464) in nadroparin-treated patients and 12.6% (61/486) in enoxaparin-treated patients, a relative risk of 1.27 (95% confidence interval; CI: 0.93-1.74) that did not met the criterion for non-inferiority of nadroparin. The rate of proximal DVT was comparable in the two groups (3.2% vs. 2.9%, respectively), but that of symptomatic VTE was lower in nadroparin-treated patients (0.2% vs. 1.4%). There was significantly (P = 0.012) less major bleeding in nadroparin- than in enoxaparin-treated patients (7.3% vs. 11.5%, respectively). CONCLUSION: Compared with those receiving enoxaparin 4000 IU, patients treated with nadroparin 2850 IU showed a higher incidence of asymptomatic distal DVT, but a lower incidence of symptomatic VTE. Nadroparin treatment was safer in terms of bleeding risk.

Adult↗

PubMedDate not supplied

Effects of nadroparin on bone histomorphometric parameters in rats.

Nadroparin calcium is a low-molecular-weight heparin. Low-molecular-weight heparins have a number of advantages over standard heparin (heparin), but it is not clear if low-molecular-weight heparins have less effect on bones than heparin. Administration of heparin can lead to osteoporosis. The aim of the present study was to investigate the effects of nadroparin on the rat osseous system and compare them with those of heparin. The experiments were carried out on female Wistar rats (13-15 weeks old at the beginning of the experiment), divided into 5 groups: I. Control, II. Nadroparin (1000 anti-Xa IU/kg s.c. daily), III. Nadroparin (2000 anti-Xa IU/kg s.c. daily), IV. Heparin (1000 IU/kg s.c. daily), V. Heparin (2000 IU/kg s.c. daily). Nadroparin and heparin were administered for 4 weeks. Bone mass, mineral and calcium content, macrometric and histomorphometric parameters (endosteal and periosteal transverse growth, width of endosteal and periosteal osteoid, transverse cross-section area of the cortical bone in the diaphysis and of the marrow cavity in the tibia, width of epiphyseal cartilage, width of trabeculae in the epiphysis and metaphysis in the femur) were examined. The effect of heparin on the ratio of bone mineral content to bone mass was more pronounced than that of nadroparin. Nadroparin caused unfavorable changes in the investigated bone histomorphometric parameters, similar to those caused by heparin. Nadroparin and heparin caused disorder of bone formation and intensification of bone resorption in rats.

Animals↗

PubMed1994

[Therapeutic management of superficial venous thrombosis with calcium nadroparin. Dosage testing and comparison with a non-steroidal anti-inflammatory agent].

This multicentre, randomised, open trial compared the efficacy and safety/acceptability of calcium nadroparin, a non-steroidal anti-inflammatory drug, naproxen, in the treatment of superficial venous thrombosis of the lower limbs, in 117 patients. Calcium nadroparin was given at two dosage regimens: a fixed dose (daily subcutaneous injection of 0.6 ml, i.e. 6150 anti-Xa IU, n = 38) or a dose adjusted for body weight (31.5 anti-Xa IU/kg, n = 40). The naproxen was given orally (500 mg as a single daily dose, n = 39). Treatment duration was 6 days in both groups. A very marked difference was found to the advantage of calcium nadroparin, although this difference did not reach the threshold of statistical significance with regard to repermeabilisation of the thrombosed superficial vein at the end of treatment. The most striking result concerned the regression of symptoms and signs. At the end of treatment (D7), there was a significant difference to the advantage of the calcium nadroparin groups, particularly regarding feelings of heat and redness (p < 0.001 in both cases). The persistence of symptoms and signs at 8 weeks was statistically less frequent (p = 0.007) in the calcium nadroparin groups than in the naproxen group. Efficacy did not differ between the calcium nadroparin fixed dose and calcium nadroparin weight-adjusted dose groups. No adverse events nor clinically significant laboratory abnormalities were encountered. Antithrombotic treatment of superficial venous thromboses with calcium nadroparin is well tolerated and appears to be associated with a greater improvement in symptoms and signs, in the short and mid-terms, than that obtained with an oral non-steroidal anti-inflammatory.

Adult↗

PubMed1992

Nadroparin calcium. A review of its pharmacology and clinical applications in the prevention and treatment of thromboembolic disorders.

Nadroparin calcium is a low molecular weight heparin with a mean molecular weight of 4.5 kD. Compared with unfractionated heparin, nadroparin calcium has a greater ratio of anti-factor Xa/anti-factor IIa activity. Nadroparin calcium has a longer half-life and greater bioavailability than unfractionated heparin and can be administered by subcutaneous injection once daily for prophylaxis and twice daily for treatment. In clinical trials, nadroparin calcium has been shown to be at least as effective as unfractionated heparin in preventing deep venous thrombosis (DVT) after various surgical procedures including major orthopaedic and abdominal surgery, and in maintaining the patency of the extracorporeal circulation in adults and children undergoing haemodialysis. Nadroparin calcium is well tolerated, the most common adverse event associated with its use being the development of minor haematoma at the operative incision site. In postmarketing surveillance data to date, the incidence of major haemorrhage related to nadroparin calcium use has been very low (< 1%). Nadroparin calcium has also been associated with a very low incidence of thrombocytopenia (< 0.001%). Thus, nadroparin calcium is an effective alternative to unfractionated heparin in the prophylaxis or treatment of thromboembolic venous events, with the advantages of more convenient administration and a lower incidence of thrombocytopenia.

Animals↗

PubMed2003

Use of the low-molecular-weight heparin nadroparin during pregnancy. A review.

Antithrombotic therapy is often used during pregnancy for the treatment and prevention of venous thromboembolism, the prevention of systemic embolism in patients with heart valve prostheses and the prevention of foetal loss in patients with antiphospholipid syndrome. Low-molecular-weight heparins (LMWHs), including nadroparin, have largely replaced unfractionated heparin as the anticoagulant of choice. The use of the LMWH nadroparin in pregnant women at an increased risk of thromboembolism or foetal loss is discussed in this review. Deep vein thrombosis can be effectively treated or prevented with nadroparin without any serious adverse events. Nadroparin 0.1 ml/10 kg s.c. once daily prevents thromboembolic complications in pregnant women with heart valve prostheses. Nadroparin is also effective in preventing foetal loss, through contributing to normal placental development and in decreasing the risk of premature delivery in pregnant women with antiphospholipid syndrome or women with herpes and antiphospholipid syndrome. These results demonstrate nadroparin is effective, easy to administer and associated with a low incidence of foetal and maternal complications. The use of nadroparin at a prophylactic dose of 0.3 ml (2850 IU AXa, 95 IU/kg) (for high-risk patients, 0.3-0.6 ml) s.c. once daily, and a therapeutic dose of 0.1 ml/10 kg (95 IU/kg) s.c. twice daily, is in line with the latest international guidelines of the American College of Chest Physicans.

Antiphospholipid Syndrome↗

PubMed2000

No effect of nadroparin prophylaxis in the prevention of central venous catheter (CVC)-associated thrombosis in bone marrow transplant recipients.

Complications of CVCs in 382 consecutive patients receiving a stem cell transplantation (SCT) were analysed. Early complications were pneumothorax (3.6%), haematothorax (0.5%), dislocation (3%) and dysfunction (3.6%). Eighty-seven-associated infections (22%) were observed, leading to removal of the CVC in 26 patients. More bacteraemias were associated with double- or triple-lumen CVCs, 19% vs 5% in single lumen CVCs (P < 0.0001). Coagulase-negative staphylococci were the predominant microorganisms in 72%. A special point of investigation was CVC-associated thrombosis and the prophylactic value of nadroparin. Two consecutive regimens with nadroparin were used and compared; 7 days 2850 IE nadroparin and 10 days 5700 IE nadroparin. The incidence of CVC-associated thrombosis was 6.9% in 382 patients with 390 catheters. The incidence was 8% in patients receiving one of the prophylactic nadroparin regimens compared to 6% in a comparable control group without prophylaxis. A short course of nadroparin was unable to prevent thrombotic complications after discontinuation.

Bone Marrow Transplantation↗

PubMed2000

Nadroparin in the prevention of deep vein thrombosis in acute decompensated COPD. The Association of Non-University Affiliated Intensive Care Specialist Physicians of France.

Low molecular weight heparins are as effective as unfractionated heparin in deep-vein thrombosis (DVT) prophylaxis for major surgery. However, there is no evidence nor consensus for prophylaxis in medical patients. We compared the efficacy and safety of nadroparin calcium (nadroparin) with placebo in medical patients at high risk of DVT. A total of 223 patients mechanically ventilated for acute, decompensated chronic obstructive pulmonary disease, were randomized to treatment with subcutaneous nadroparin adjusted for body weight (0.4 ml, i.e., 3,800 AXa IU, or 0.6 ml, i.e., 5,700 AXa IU) or placebo. The average duration of treatment was 11 d. The incidence of DVT in patients receiving nadroparin was significantly lower than that in patients receiving placebo (15.5 versus 28.2%; p = 0.045). Although the incidence of adverse events was high in both groups, there were no significant differences between nadroparin and placebo for total adverse events (46.3 versus 39.8%; p = 0.33), serious adverse events (25.0 versus 19.5%; p = 0.32), or those resulting in early permanent discontinuation of treatment (12.0 versus 8.8%; p = 0.44). The most common adverse event was hemorrhage. There was the same number of deaths in both treatment groups. Subcutaneous nadroparin resulted in 45% decrease in incidence of DVT compared with placebo.

Aged↗

PubMedDate not supplied

Economic evaluation of the use of nadroparin in the treatment of deep-vein thrombosis in Switzerland.

OBJECTIVE: To compare the cost implications, from the payer's perspective, of the use of nadroparin instead of unfractionated heparin in the initial treatment of deep-vein thrombosis. DESIGN: Cost-minimization study. SETTING: Switzerland. MATERIAL: Survey of clinical practice in six Swiss hospitals used to model three treatment regimens. MAIN OUTCOME MEASURES: Cost of treatment ($ US) per patient. RESULTS: Treatment with nadroparin instead of unfractionated heparin would reduce costs by $153 per patient. Treatment with nadroparin instead of subcutaneous unfractionated heparin would reduce costs by $109 per patient. CONCLUSIONS: The cost of initial treatment of deep-vein thrombosis is considerably lower with nadroparin than with either of the alternative regimens. Nadroparin reduces costs through greater ease of administration and by reducing the amount of laboratory monitoring. Treatment with nadroparin might also allow patients to be discharged from the hospital more quickly than is possible with intravenous infusion of unfractionated heparin.

Anticoagulants↗

PubMed2007

Inhibition of clot formation process by treatment with the low-molecular-weight heparin nadroparin in patients with carotid artery disease undergoing angioplasty and stenting. A thromboelastography study on whole blood.

Low-molecular-weight heparins (LMWHs) have become the corner stone of antithrombotic treatment but their administration protocol needs to be optimized for certain groups of patients. In this paper, we studied the influence of nadroparin treatment on clot formation process assessed by thromboelastography in patients with carotid artery disease undergoing angioplasty and stenting. Standard thromboelastography assays (in-TEM and ex-TEM) and minimal TF-triggered thromboelastography assay in citrated whole blood were performed in normal volunteers (n = 20), in patients with carotid artery disease receiving only antiplatelet treatment (n = 30), and in patients undergoing angioplasty receiving nadroparin 5750 anti-Xa IU s.c. twice daily (n = 60). Blood samples were collected four hours after a second injection of nadroparin. In a subgroup of LMWH-patients (n = 18) blood samples were also obtained prior to first injection of LMWH. Antiplatelet treatment had no effect on any parameter of the thromboelastographic pattern. Nadroparin treatment resulted in significant prolongation of clotting time (CT) and clot formation time (CFT) and significantly reduced a -angle in minimal TF-triggered thromboelastography and 30 - 38% of nadroparin treated patients had thromboelastographic parameters beyond the normal maximum limit. In-TEM test revealed a significant prolongation of clotting time while ex-TEM was not modified, and 20 to 30% of the patients had thromboelastographic parameters beyond the normal maximum limit. Anti factor-Xa activity in platelet-poor plasma (PPP) was also measured, and statistical analysis showed that prolongation of CFT of minimal TF-triggered TEM was significantly correlated to the levels of anti-Xa activity in patients ' plasma (p = 0.04; r (2) = 0.7). There was no statistical correlation for any other parameter in all tests. In conclusion, the present study shows that nadroparin treatment in patients with carotid artery disease undergoing endovascular procedures induces significant modification of the thrombus kinetics assessed by minimal TF-triggered whole blood thromboelastography. The clinical relevance of these findings has to be evaluated in future studies.

Aged↗

PubMed2003

Postoperative nadroparin administration for prophylaxis of thromboembolic events is not associated with an increased risk of hemorrhage after spinal surgery.

AIM: To determine the risk of postoperative hemorrhage during a 3-year period of early postoperative administration of nadroparin (Fraxiparin) plus compression stockings in a large cohort of patients who underwent spinal surgery. METHODS: A total of 1,954 spinal procedures at different levels (503 cervical, 152 thoracic and 1,299 lumbar), performed between June 1999 and 2002 at the Department of Neurosurgery, Johann-Wolfgang-Goethe University Frankfurt, were included in this study. To prevent venous thromboembolic events (VTE), all patients were routinely treated subcutaneously with 0.3 ml of early (less than 24 h) postoperative nadroparin calcium (Fraxiparin) (2850 IU anti-Xa, Sanofi Winthrop Industrie, France) plus intra- and postoperative compression stockings until discharge. The occurrence of a postoperative hematoma (defined as a hematoma requiring surgical evacuation because of space occupation and/or neurological deterioration) and a deep venous thrombosis (DVT) were recorded in a database and analyzed retrospectively. RESULTS: 13 (0.7%) of the 1,954 spinal operations were complicated by major postoperative hemorrhages. In 5 of the 13 patients (38.5%) the hemorrhage occurred on the day of surgery before the administration of nadroparin. Thus, the hemorrhage rate of patients receiving nadroparin was 0.4% (8/1,949). Ten (77%) of the 13 patients with major postoperative hematoma showed a progressive neurological deficit, which resolved in 6 patients and resulted in a hematoma-related morbidity of 31% (4/13). Only 1 patient (0.05%) in this series developed a clinically evident DVT, and none of the patients suffered from pulmonary embolus during the hospital stay. CONCLUSION: Although retrospective, this is to date the largest study providing information about the hemorrhage rate associated with early postoperative anticoagulation following spinal surgery. The results confirm that early postoperative pharmacological thromboembolic prophylaxis using nadroparin in patients with spinal surgery is not associated with an increased risk of postoperative hemorrhage.

Adult↗

PubMed2006

Nadroparine activated fibrinolysis and improvement of glomerular filtration rate in patients with FIGO IIB-IIIB cervical cancer treated with radiochemotherapy.

OBJECTIVES: (1) Evaluation of the influence of hemostatic disorders on renal function in patients with FIGO stage IIB-IIIB cervical cancer treated with radiochemotherapy. (2) Identifying methods of improving renal function in this patients group. METHODS: Treatment design assumes the administration of a total radiation dose of 46-65 Gy and, additionally, cisplatin 40 mg/m2 every 7 days in patients with normal plasma creatinine level. Renal function was assessed with the aid of dynamic scintigraphy with glomerular filtration rate (GFR) evaluation. Analysis of serum hemostatic system covered D-dimers, PAP, PAI-1, tPA, FDP, F1+2 and TAT. The same hemostatic parameters were also evaluated in urine. The patients were divided into two groups: the study group - i.e. patients with affected GFR and the control group - with normal GFR. Half of study group patients, throughout the entire treatment, receive nadroparine 2850 units aXa/0.3 ml every 24 h during and 6 weeks after the treatment. RESULTS: There are significant decreases of GFR in control (median -9.7%) and study group without nadroparine (median -9.9%) and increase in the GFR (median 22.3%) in study group with nadroparine (p=0.0001). Plasma and urine hemostatic parameter analysis showed activation of fibrinolysis in patients treated with nadroparine and fibrinolysis inhibition in remaining groups. CONCLUSIONS: (1) Inhibition of fibrinolysis may cause subclinical renal insufficiency in patients with advanced cervical cancer. (2) Insufficiency increases after the end of radiochemotherapy in patients, as well with normal GFR as, with primary decreased GFR. (3) Application of nadroparine causes fibrinolysis activation, and increase in the GFR.

Adult↗

PubMed2000

Efficacy and safety of weight-adapted nadroparin calcium vs. heparin sodium in prevention of clinically evident thromboembolic complications in 1,190 general surgical patients.

AIMS: In a prospective, randomized, single, general surgery center trial, comparison of the safety and efficacy of two low molecular weight heparin (LMWH; anti-Xa heparin sodium and weight-adapted nadroparin calcium) regimens was made. PATIENTS AND METHODS: Eleven hundred and ninety patients undergoing various elective and emergency operations were randomized to receive daily either a fixed dose of 3,000 IU anti-Xa heparin sodium or a variable body weight-dependent dose of nadroparin calcium (weight <50 kg, 2,050 IU anti-Xa (WHO); 51-80 kg, 3,075 UI; 81-100 kg, 4,100 UI, and >100 kg, 6,150 UI) once until discharge. The first injection was administered 2.5-6 h before elective and emergency operations, respectively. Patients with clinical suspicion of deep venous thrombosis (DVT) underwent phlebography. Patients with signs of pulmonary embolism (PE) were further investigated by a ventilation-perfusion scan. RESULTS: Statistically, there were no significant differences in the incidence of clinically evident DVT, PE or LMWH-related complications between both prophylactic regimens. Only 4 of the total of 15 hemorrhagic complications (4 wound hematomas in the nadroparin calcium group) were not classified as clearly surgically related, Two DVTs were confirmed by phlebography (both in the nadroparin calcium group). PE was confirmed by ventilation-perfusion scans (1 fatal, 1 on autopsy) in 1 patient with heparin sodium and in 6 patients with nadroparin calcium. CONCLUSIONS: Both regimens were equally safe and the risk of clinically evident DVT and PE was similar.

Anticoagulants↗