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PubMed1988

Comparison of a low molecular weight heparin and unfractionated heparin for the prevention of deep vein thrombosis in patients undergoing abdominal surgery. The European Fraxiparin Study (EFS) Group.

In a prospective, randomized multicentre trial the efficacy and safety of the low molecular weight heparin (LMWH) fraction Fraxiparin and unfractionated calcium heparin (Calciparin) were compared for the prevention of postoperative deep vein thrombosis. Of 1909 patients included in the trial 1896 underwent abdominal surgery and received either one daily subcutaneous injection of 7500 anti-Xa units Fraxiparin or 5000 units calcium heparin three times a day subcutaneously. Elastic compression stockings were worn by both groups of patients in the postoperative period. Before randomization the patients were stratified in two subgroups with or without malignant disease. To assess the rate of deep vein thrombosis (DVT), 125I-labelled fibrinogen leg scanning was performed daily for 7 postoperative days. Positive results were confirmed by phlebography whenever possible. Venous thrombosis occurred in 27 of 960 patients (2.8 per cent) given Fraxiparin and in 42 of 936 patients (4.5 per cent) given calcium heparin (P = 0.034). The rates of proximal vein thrombosis were 0.4 per cent (4 patients) and 1.4 per cent (13 patients) respectively (P less than 0.05). Pulmonary embolism occurred in 2 of 960 patients (0.2 per cent) treated with Fraxiparin and in 5 of 936 patients (0.5 per cent) treated with calcium heparin. The two treatments were equally well tolerated. Intra- and postoperative blood loss, the number of wound haematomas as well as frequency and volume of transfusions were similar in both groups. The present trial demonstrates that a single daily subcutaneous injection of Fraxiparin is more effective than the established low dose subcutaneous heparin prophylaxis with 5000 units three times per day in preventing postoperative DVT after abdominal surgery in patients wearing compression stockings.

Abdomen↗
PubMed1994

Anticoagulant therapy in deep venous thrombosis. A randomized controlled study.

Ninety patients with venographically proven deep venous thrombosis(DVT) but without clinical signs of pulmonary embolism(PE) were randomized into two different treatment regimens to compare the safety and efficacy of continuous intravenous heparin and oral anticoagulant(AC) treatment versus non-AC treatment. All patients in the two treatment groups were actively mobilized from the day of admission and wore graduated compressing stockings. In the non-AC-group the patients were treated with phenylbutazone for ten days. Treatment with heparin was maintained for 6 days and oral AC treatment was given from the third day and continued for 3 months. Venography was repeated after 30 days. A perfusion-ventilation lung scan was performed on day 1-2, 10 and 60. In fifty-nine patients a revenography was performed, twenty nine in the AC-group and thirty in the non-AC group. For distal veins regression was found in nine and eight respectively (4.4% in favour of AC, 95% confidence limit 27.5% to -18.7%) and in proximal veins regression was found in five and eight, respectively (10.9% in favour of AC, 95% confidence limit 32.0% to -10.1%). No difference in lung scans was found after 10 days (0.8% in favour of AC, 95% confidence limit 21.5% to -19.9%) or after 60 days (3.3% in favour of non-AC treatment, 95% confidence limit 21.8% to -28.5%). In the AC group the incidence of bleeding complications was 8.3%. No side-effects of phenylbutazone was found. The present controlled clinical study demonstrated no effect of AC-treatment on DVT progression in actively mobilized patients wearing graduated compressing stockings when compared to a non-AC treated group receiving analgetic therapy with phenylbutazone. However, the patient population of the study is relatively small with wide confidence intervals for differences between groups. Before more general recommendations can be made, a large scale placebo-controlled study is needed to evaluate the possible effect of AC-treatment in DVT patients, who can be mobilized from the first day.

Administration, Oral↗
PubMed2000

Heparin, low molecular weight heparin and physical methods for preventing deep vein thrombosis and pulmonary embolism following surgery for hip fractures.

BACKGROUND: Hip fracture patients have a high risk of thromboembolic complications following surgical management. OBJECTIVES: To examine the effects of heparin (unfractionated (U), and low molecular weight (LMW) heparins), and physical methods (compression stockings, calf or foot pumps) for prevention of deep venous thrombosis (DVT) and pulmonary embolism after surgery for hip fracture in the elderly. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group trials register, Medline, Embase, and reference lists of published papers and books. We contacted trialists and other workers in the field. Date of most recent search: September 1996. SELECTION CRITERIA: Randomised and quasi-randomised trials evaluating the use of heparins and physical agents for prevention of DVT and pulmonary embolism in patients undergoing surgery for hip fracture. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed methodological quality and extracted data. Trials were grouped into four categories (heparin versus control, mechanical versus control, LMW heparin versus U heparin, and miscellaneous) and results pooled where possible. MAIN RESULTS: The 26 included trials involved 2600 predominantly female and elderly patients. Overall, trial quality was disappointing. Ten trials involving 826 patients which compared U heparin with control, and four trials of 471 patients which compared LMW heparin with control, showed a reduction in the incidence of lower limb DVT (121/511 (24%) versus 203/519 (39%); Peto odds ratio 0.41; 95% confidence interval 0.31 to 0.55). There were insufficient data to confirm the efficacy of either agent in the prevention of pulmonary embolism. There was a non significant increase in overall mortality in the heparin group (46/420 (11%) versus 35/423 (8%); Peto odds ratio 1.39; 95% confidence interval 0. 86 to 2.23). Data were inadequate for all other outcomes including wound complications. There is insufficient evidence from five trials, involving 644 patients, to establish if LMW heparin was superior to U heparin. Most trials evaluating heparins had methodological defects. Four trials, involving 442 patients, testing mechanical pumping devices were also methodologically flawed, and so pooled results need to be viewed cautiously. Mechanical pumping devices may protect against DVT (12/202 (6%) versus 42/212 (19%); Peto odds ratio 0.24; 95% confidence interval 0.13 to 0.44). Although the limited data indicated a potential benefit, they were inadequate to establish any effect on the incidence of pulmonary embolism and overall mortality. Problems with skin abrasion and compliance were reported. REVIEWER'S CONCLUSIONS: U and LMW heparins protect against lower limb DVT. There is insufficient evidence to confirm either protection against pulmonary embolism or overall benefit, or to distinguish between various applications of heparin. Foot and calf pumping devices appear to prevent DVT, may protect against pulmonary embolism, and reduce mortality, but compliance remains a problem. Good quality trials of mechanical methods as well as direct comparisons with heparin should be considered.

Anticoagulants↗
PubMed2000

Efficacy of orally administered extract of red vine leaf AS 195 (folia vitis viniferae) in chronic venous insufficiency (stages I-II). A randomized, double-blind, placebo-controlled trial.

UNLABELLED: Red vine leaf extract (RVLE) is a herbal medicine containing several flavonoids, with quercetin-3-O-beta-glucuronide and isoquercitrin (quercetin-3-O-beta-glycoside) as the main components. OBJECTIVE: To assess the efficacy and safety of once-daily doses of 360 and 720 mg RVLE (pharmaceutical extract code AS 195; Antistax Venenkapseln) compared to placebo in patients with stage I and incipient stage II chronic venous insufficiency (CVI). DESIGN: A 12-week, randomized, double-blind, placebo-controlled, parallel-group, multi-center study. PATIENTS: Male and female outpatients aged 25 to 75 years with stage I to stage II CVI (i.e. without extensive trophic changes), not having any other significant medical conditions and not treated with compression stockings, diuretics or other drugs affecting fluid balance. INTERVENTION: Patients were randomly assigned to a double-blind treatment with placebo, 360 mg AS 195 or 720 mg AS 195 once daily for 12 weeks, preceded and followed by a single-blind 2-week placebo treatment for baseline run-in and end-of-trial washout, respectively. Study criteria were evaluated at baseline, after 6 and 12 weeks of treatment and 2 weeks after discontinuation of treatment. RESULTS: Of the 260 patients enrolled and randomized, 219 completed the study in accordance with the protocol. In the intention-to-treat analysis (N = 257), the mean (+/- SD) lower leg volume (measured by water displacement plethysmography) of the patients treated with placebo (N = 87) increased by 15.2 +/- 90.1 g (displaced water mass) and by 33.7 +/- 96.1 g after 6 and 12 weeks compared to baseline. In contrast, for patients treated with AS 195, lower leg volume decreased, and after 12 weeks of treatment, the difference in mean lower leg volume between the active treatment groups and the placebo group was -75.9 g (95% CI: -106.1 to -45.8 g) and -99.9 g (95% CI: -130.3 to -69.6 g) for the group treated with 360-mg AS 195 (N = 86) and 720-mg AS 195 (N = 84), respectively. The changes in calf circumference showed a similar pattern: in patients treated with AS 195, both the higher dose (720 mg) and, albeit to a lesser extent, the lower dose (360 mg) resulted in a clear reduction in circumference over time, whereas, circumference remained largely unchanged in patients treated with the placebo (95% CI of the estimated treatment effects vs. placebo after 12 weeks: -1.40 to -0.56 cm and -1.73 to -0.88 cm for 360 and 720 mg AS 195, respectively). These differences were statistically significant (p < 0.001). The reductions in ankle circumference were qualitatively similar but quantitatively less marked. Subjectively, there was an improvement in key CVI symptoms (VAS) at 6 weeks with all treatments, but a further improvement at week 12 was seen only in the active treatment groups; at 12 weeks, the changes compared to baseline were significantly greater (p < 0.001) in both active treatment groups than in the placebo group. The treatments were well tolerated; Adverse events were rare and usually mild. Two adverse events (AEs) during treatment with the placebo led to hospitalization and were hence labeled as 'serious'. Three further patients were withdrawn because of AEs which occurred during treatment with the placebo. CONCLUSION: Once-daily doses of 360 and 720 mg AS 195 were confirmed to be safe and effective in the treatment of mild CVI, reducing significantly lower leg edema and circumference whilst improving key CVI-related symptoms to a clinically relevant extent. The edema reduction is at least equivalent to that reported for compression stockings and/or other edema-reducing agents. The higher dose was as well tolerated as the lower dose but resulted in a slightly greater and more sustained improvement.

Adult↗
PubMed1989

[Indications-related use of stockings--measuring venous pump function].

In 48 patients (16 healthy persons, 16 patients with venous incompetence and 16 patients with phlebographic proved status after thrombosis) the effect of medical compression stockings of different compression pressure (Sigvaris Thrombo, Sigvaris 503, Sigvaris 504) on venous pumping function was studied by foot volumetry. In patients with varicosis and preexistent reduced pumping function the expelled volume in average ascended from 13.0 to 16.23 (+25%, Sigvaris 503), respectifly to 16.52 (+27%, Sigvaris 504) (p less than 0.05 Wilcox and Wilcoxon test). In patients in status after deep leg vein thrombosis with very reduced pumping function it came to an increase of expelled volume from 8.48 to 11.08 (+31%, Sigvaris 503) and to 12.55 (+48%, Sigvaris 504) (p less than 0.01). The hospital stocking Sigvaris Thrombo did not really improve the venous pumping function. So for the first time the common prescription of medical compression stockings class II in patients with varicosis and in mild cases of chronic venous incompetence and of stockings class III in patients in status after deep leg vein thrombosis is justified by measurement.

Adolescent↗
PubMed1995

Postoperative hypercoagulability and deep-vein thrombosis after laparoscopic cholecystectomy.

Patients who undergo laparoscopic cholecystectomy (LC) are operated on under general anesthesia, in a reverse Trendelenburg position, with 12-15-mmHg pneumoperitoneum. All of these factors can induce venous stasis of the legs, which may lead to postoperative deep-vein thrombosis (DVT). The objectives of this study were to assess the degree of hypercoagulability and to determine the rate of postoperative DVT in a group of 100 patients in whom LC was completed. Whole-blood thrombelastography (TEG) and plasma-activated partial thromboplastin time (PTT) determination were carried out preoperatively and on the 1st postoperative day. All patients received pre-, intra-, and postoperative graduated compression stockings and sequential pneumatic compression devices until fully ambulatory. Twenty-six percent of the patients with a risk score > 4, or a post-operative TEG index > +5.0, received subcutaneous heparin (5,000 units b.i.d.), beginning in the postoperative period and continuing for 4 weeks as an outpatient. A complete venous duplex scan of both legs was performed on the 7th postoperative day, at the time of their office visit. Our results revealed significant postoperative hypercoagulability for the TEG index (P < 0.005) and for PTT (P < 0.05). One patient had an asymptomatic DVT (1%), and no side effects from the mechanical or pharmacological prophylaxis occurred in this series. These data suggest that the low incidence of thrombosis in the face of theoretical and laboratory evidence of postoperative hypercoagulability may reflect an effective prophylactic regime.(ABSTRACT TRUNCATED AT 250 WORDS)

Bandages↗
PubMed2005

A case of suspected severe pulmonary embolism in a living-related liver transplantation donor.

Optimal safety for a donor is an essential condition for living-related liver transplantation (LRLT). Severe pulmonary embolism may be a rare complication for the donors, but it is potentially fatal. Various risk factors and prophylactic methods for thromboembolic complications have been described. We report here a case of severe pulmonary embolism in a living-related liver transplantation donor who underwent right liver lobectomy, although the patient had no apparent risk factor for thromboembolism except for slight obesity (body mass index = 27). In addition, the donor received prophylactic use of graduated compression stockings and intermittent pneumatic compression by use of a special device from the start of anesthesia until the patient was able to ambulate. Fortunately, the patient was successfully treated with urokinase and heparin infusion followed by warfarin administration.

Adult↗
PubMed2000

Prevention of venous thromboembolism.

Venous thromboembolism is the most common cause of preventable death among hospitalised patients. Systematic prophylaxis with antithrombotic agents in patients at risk for venous thromboembolism is the most effective approach to reduce morbidity and mortality. Despite this evidence, antithrombotic prophylaxis is still underused, due to the underestimation of incidence of venous thromboembolism and to the unjustified fear of bleeding complications. Both the characteristics of the individual patient and the clinical setting contribute to the definition of the risk for venous thromboembolism. Patient-related risk factors include clinical and molecular abnormalities. The grade of risk for venous thromboembolism is defined better by the clinical setting than by the patient characteristics. Prophylactic studies have been extensively carried out in surgical patients and, only more recently, in medical patients. Prophylactic methods include pharmacological agents, such as heparin, low molecular weight heparins, warfarin, and hirudin, as well as mechanical methods such as compression stockings and intermittent pneumatic compression.

Anticoagulants↗
PubMedDate not supplied

Perioperative deep vein thrombosis in Chinese patients undergoing craniotomy.

BACKGROUND: We attempted to determine the incidence of perioperative deep vein thrombosis (DVT) in Chinese patients undergoing elective craniotomy for brain tumors and to assess the efficacy of clinical and serial calf circumference assessment in detecting DVT. METHODS: Between June 1999 and February 2001, 100 consecutive patients who underwent elective craniotomy for brain tumors at the Department of Neurosurgery, University of Hong Kong Medical Centre were examined for perioperative DVT. The demographic data, Glasgow coma score (GCS), mobility status, and the operative details were recorded. Graduated compression stockings and intermittent pneumatic compression were applied perioperatively as prophylaxis against DVT. Serial duplex scans were performed before and after operation. Clinical examination was also performed daily to look for signs of DVT. The calf circumference was measured at fixed levels for both limbs before each duplex scan surveillance. RESULTS: The study group consisted of 44 males and 56 females, with a mean age of 54 +/- 15 years (range, 20-81 years). There was no preoperative DVT. Postoperative DVT was detected on duplex scan in four patients (4%), two of whom had bilateral involvement. The thrombosis was confined to the calf veins in two limbs. The demographic data, neurologic status and operative details of patients with and without DVT were similar. Patients with DVT had no clinically recognizable signs. The change in calf circumference measurement was also not predictive of DVT. CONCLUSIONS: The incidence of perioperative DVT in Chinese patients undergoing elective craniotomy for brain tumors appears to be low with the present mechanical prophylactic measures. Given the low incidence of proximal DVT as detected by duplex scan, the use of heparin prophylaxis may not be justified because of the increased risk of intracranial bleeding. Clinical assessment with calf circumference measurement is unreliable in the diagnosis of DVT.

Adult↗
PubMed2005

Venous thromboembolism in radical prostatectomy: is heparinoid prophylaxis warranted?

OBJECTIVE: To review the incidence of venous thromboembolism (VTE) after radical retropubic prostatectomy (RRP) and evaluate the need for heparinoid prophylaxis as opposed to mechanical compression devices after RRP. PATIENTS AND METHODS: RRP is classified as a category 1 (high risk) procedure for VTE by the American College of Chest Physicians and several international guidelines recommend subcutaneous heparinoids as the preferred prophylaxis. However, this regimen may be associated with a greater risk of bleeding. We have not used heparinoid prophylaxis but place a mechanical compression device for prophylaxis of VTE, and report our clinical experience over a 12-year period. Between 1992 and 2004, all RRPs carried out by one surgeon (M.S.S.) at our centre were retrospectively reviewed after obtaining institutional review board approval. The protocol for prophylaxis of VTE consisted of compression stockings and a sequential compression device from the time of entry into the operating room until complete ambulation (we encourage early ambulation). Patients were evaluated for VTE if they developed any clinical signs or symptoms. Patients were followed at 7 days, 6 weeks and 3 months after RRP in the first year and 6-monthly thereafter. All relevant clinical data and complications were entered in a database. RESULTS: In all there were 1364 RRPs; the mean (sd) age of the patients was 61 (7) years and the mean follow-up 44 (38) months. All patients had a mechanical compression device and ambulated on the first day after surgery. None received heparinoid prophylaxis. Three VTE events were identified (0.21%); two patients had a lower limb VTE and one an upper limb VTE. All were successfully treated with anticoagulation. No patient had a documented pulmonary embolus and none died from VTE. There was one death after RRP, from myocardial infarction. CONCLUSION: The incidence of VTE after RRP is low, possibly related to the use of a mechanical compression device and early aggressive mobilization. Despite the recommendations by some, we feel that routine heparinoid prophylaxis is questionable.

Aged↗
PubMed1999

Venous ulcer reappraisal: insights from an international task force. Veines International Task Force.

UNLABELLED: An international task force made up of a panel of 16 experts was mandated to review and objectively evaluate all aspects of chronic venous disease of the leg. All available publications on chronic venous disease of the leg from 1983 to 1997 were identified through computerized search. Three different screenings were then performed in order to select only relevant papers providing moderate to strong scientific evidence. Final conclusions and further therapeutic recommendations were made based on these publications. Compression, medications, local therapies, sclerotherapy and surgery are the existing therapeutic options for which the following recommendations can be made. Compression: Properly applied bandages both fixed and stretched have been shown to be effective. Compression stockings may be used. Compression needs to be in excess of 35 mm Hg. Medications: Although preliminary results have shown a beneficial effect of several vasodilators and oral micronized purified flavonoid fraction, the evidence for the efficacy of medications on venous ulcer healing is still limited and further studies are required before recommendations can be made. There is no evidence to routinely administer antibiotics. Local therapies have an as yet unproven adjunctive role. Sclerotherapy is unlikely to be effective unless there is superficial venous insufficiency, in which it may have an as yet unproven role. SURGERY: Patients with active venous ulcer and sapheno-femoral or sapheno-popliteal junction incompetence benefit from surgical treatment. In the absence of reflux or following deep vein thrombosis, there is no evidence to support surgical treatment.

Algorithms↗
PubMed2004

Prevention of venous thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy.

This article discusses the prevention of venous thromboembolism (VTE) and is part of the Seventh American College of Chest Physicians Conference on Antithrombotic and Thrombolytic Therapy: Evidence-Based Guidelines. Grade 1 recommendations are strong and indicate that the benefits do, or do not, outweigh risks, burden, and costs. Grade 2 suggests that individual patients' values may lead to different choices (for a full understanding of the grading see Guyatt et al, CHEST 2004; 126:179S-187S). Among the key recommendations in this chapter are the following. We recommend against the use of aspirin alone as thromboprophylaxis for any patient group (Grade 1A). For moderate-risk general surgery patients, we recommend prophylaxis with low-dose unfractionated heparin (LDUH) (5,000 U bid) or low-molecular-weight heparin (LMWH) [< or = 3,400 U once daily] (both Grade 1A). For higher risk general surgery patients, we recommend thromboprophylaxis with LDUH (5,000 U tid) or LMWH (> 3,400 U daily) [both Grade 1A]. For high-risk general surgery patients with multiple risk factors, we recommend combining pharmacologic methods (LDUH three times daily or LMWH, > 3,400 U daily) with the use of graduated compression stockings and/or intermittent pneumatic compression devices (Grade 1C+). We recommend that thromboprophylaxis be used in all patients undergoing major gynecologic surgery (Grade 1A) or major, open urologic procedures, and we recommend prophylaxis with LDUH two times or three times daily (Grade 1A). For patients undergoing elective total hip or knee arthroplasty, we recommend one of the following three anticoagulant agents: LMWH, fondaparinux, or adjusted-dose vitamin K antagonist (VKA) [international normalized ratio (INR) target, 2.5; range, 2.0 to 3.0] (all Grade 1A). For patients undergoing hip fracture surgery (HFS), we recommend the routine use of fondaparinux (Grade 1A), LMWH (Grade 1C+), VKA (target INR, 2.5; range, 2.0 to 3.0) [Grade 2B], or LDUH (Grade 1B). We recommend that patients undergoing hip or knee arthroplasty, or HFS receive thromboprophylaxis for at least 10 days (Grade 1A). We recommend that all trauma patients with at least one risk factor for VTE receive thromboprophylaxis (Grade 1A). In acutely ill medical patients who have been admitted to the hospital with congestive heart failure or severe respiratory disease, or who are confined to bed and have one or more additional risk factors, we recommend prophylaxis with LDUH (Grade 1A) or LMWH (Grade 1A). We recommend, on admission to the intensive care unit, all patients be assessed for their risk of VTE. Accordingly, most patients should receive thromboprophylaxis (Grade 1A).

Anticoagulants↗
PubMed2003

[Prevention of thrombo-embolic venous disease].

Large epidemiological studies have shown that nearly all risk factors for deep vein thromboses have a different impact on the manifestation of the disease, which aids in their differentiation into high, moderate and low risk. North American authors have introduced a fourth class of very high risk. The prophylactic measures available are numerous. They can be used in isolation or association depending on the significance of the risk. In France, prophylaxis by LMWH (low molecular weight heparin) is by far the most frequently used method. Recently, apart from compression stockings and intermittent mechanical compression, the use of footpumps, and a technique of electrical calf stimulation have been proposed. Each thrombosis center or service should put in place a well defined strategy for prescribing thromboprophylaxis, adapted to the level of the thromboembolic risk for each group of patients. A dose of LMWH higher than that used for a moderate risk is indicated for most LMWH, in the case of a high or very high risk. A few problems still exist: the pre or postoperative timing of the first injection, the duration of the prophylaxis particularly during the post-discharge period, and the evaluation of the risk in certain situations such as laparoscopic surgery or limb immobilization, for which the studies are too few to formulate recommendations from the level of evidence available. The socioeconomic realities of using LMWH should not be ignored.

Humans↗
PubMed1991

Prophylaxis of deep venous thrombosis and pulmonary embolism.

Clinically silent deep venous thrombosis (DVT) develops in up to 25% of patients who undergo general surgical procedures. Approximately 10% of these thromboses are complicated by potentially fatal pulmonary embolism. Two recent meta-analyses of more than 70 published trials of DVT prophylaxis in general surgery have demonstrated conclusively that prophylaxis significantly reduces rates of DVT and fatal pulmonary embolism and results in improved overall survival. Physical methods of prophylaxis, including compression stockings and intermittent pneumatic compression, are as effective as pharmacologic prophylaxis (the most common regimen being heparin, 5000 units subcutaneously ever 8 to 12 hours). Bleeding complications are increased with the use of heparin, although they are clinically minor. Deep venous thrombosis prophylaxis should be routinely instituted for all general surgical patients who undergo major operative procedures.

Heparin↗
PubMed1995

Venous thromboembolism. Risk factors and prophylaxis.

Most deaths from pulmonary embolism can be prevented by providing adequate prophylaxis for hospital patients who are at high risk for venous thromboembolism. Physicians, however, must be able to identify high-risk patients (including those with major trauma, hip or knee replacement, or pelvic fractures) and prescribe an appropriate prophylactic agent for each patient according to his or her level of risk. A number of prophylactic methods have been proven effective in the prevention of venous thromboembolism, including low-dose heparin, low-molecular-weight heparin, warfarin, graduated compression stockings, and intermittent pneumatic compression of the legs.

Adult↗