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Randomized clinical trial of intermittent pneumatic compression and low molecular weight heparin in trauma.

BACKGROUND: After trauma, up to 60 per cent of immobilized patients have been reported to develop a silent deep vein thrombosis (DVT). No large, prospective randomized trials have tested the efficacy of intermittent pneumatic compression (IPC) devices in these patients. METHODS: A prospective randomized trial was performed of 442 patients who received thromboprophylaxis using either an IPC device or low molecular weight heparin (LMWH). Duplex imaging was performed on both legs on admission, and was repeated weekly thereafter until discharge, at 30 days or when there was a thrombotic event, whichever occurred first. RESULTS: There were no significant differences in time spent in intensive care, or the proportion of patients with pelvic fractures, spinal cord or head injuries between the two groups. Six patients (2.7 per cent) developed a DVT in the IPC group and one (0.5 per cent) in the LMWH group (P = 0.122). Pulmonary embolism occurred in one patient in each group. There were 13 minor bleeding episodes (four in the IPC group and nine in the LMWH group) and eight major bleeding episodes (four in each group), none of which required operative intervention. CONCLUSION: The low rate of thromboembolic complications and the cost savings suggest that IPC might be used safely and effectively for thromboprophylaxis in trauma patients.

Adult↗

Posttraumatic thromboprophylaxis revisited: an argument against the current methods of DVT and PE prophylaxis after injury.

BACKGROUND: Thromboprophylaxis after injury is a controversial issue. Practices and outcomes vary widely. METHODS: Review of selected trauma literature on venous thromboprophylaxis after injury. RESULTS: Multiple trauma articles suggest that the efficacy of different methods of thromboprophylaxis is unproven. Most of the practices on this issue are extrapolated from studies which were performed in non-trauma patients and therefore, may not be applicable in the unique trauma population. CONCLUSIONS: In the absence of undisputable evidence, none of the current methods of venous thromboprophylaxis after injury should be considered as standard of care. There is a need to discover new methods of thromboprophylaxis for the Trauma patient.

Anticoagulants↗

Effect of intermittent compression therapy on bone mineral density in women with low bone mass.

Intermittent pneumatic compression has been shown to increase blood flow in the leg which, in turn, may improve BMD. We performed a pilot study to assess whether intermittent compression of the leg could improve BMD at the femoral neck. 37 postmenopausal women with low bone density T score < -1 at either hip or spine were recruited into the study of whom 24 completed. Women applied intermittent compression for 2 h a day for 6 months to each leg in turn. The study lasted 1 year. Women were also given daily 1 g of Calcium and 800 IU of vitamin D (Calcichew D 3 forte Shire, UK). Lumbar spine BMD decreased by 0.5% at 12 months compared with baseline (mean difference 0.005 g/cm(2), 95% C.I -0.2287 to 0.03459, P = 0.28). At 12 months the right femoral neck BMD increased by 3% compared with baseline (mean 0.811 +/- 0.08, P = 0.22), while the left increased 2% (0.783 +/- 0.06, P = 0.16). There was no change in BMD at the distal tibia or heels and no site effect of the compression. The fat mass decreased by 4.6% in the right leg and 5% in the left leg (P = 0.005 and 0.003, respectively). Tissue thickness did not change. The analysis of the interaction between the degree of exercise and change in BMD showed a statistically significant increase in right femoral neck BMD following 6 months of right leg intermittent compression, but only in women whose exercise was minimal (P = 0.029). This effect was not seen in the left femur possibly due to the reduced number of patients who completed the study in this group. These preliminary results indicate that intermittent pneumatic leg compression may have a role in osteoporosis prevention. It may provide a mean of inhibiting decline in femoral neck BMD, particularly in sedentary women.

Aged↗

Interventions for leg edema and varicosities in pregnancy. What evidence?

Leg oedema from venous insufficiency is not dangerous but it can cause women symptoms such as pain, feelings of heaviness, night cramps and paraesthesiae. Leg oedema can be a sign of pre-eclampsia when associated with raised blood pressure or proteinuria. The objective of this review was to assess the effects of treatment to relieve the symptoms associated with varicosity in pregnancy and to reduce leg oedema. We searched the Cochrane Pregnancy and Childbirth Group trials register in October 2004 for randomised trials of any form of treatment for varicosity and or leg oedema in pregnancy. Trial quality was assessed and data were extracted. Four trials of three different treatments were included. In one trial, women given rutoside capsules in the last 3 months of pregnancy noted an improvement in symptoms compared with placebo (relative risk 0.54 95% CI 0.32, 0.89). They had a decrease in ankle circumference at 36 weeks' gestation after 8 weeks of treatment, while women given placebo had a small increase. In one trial, women with ankle oedema had a small non-significant reduction in lower leg volume when treated with external pneumatic intermittent compression for 30 min. In another trial compression stockings prophylactically reduced the emergence of leg symptoms but not venous varicosities (relative risk 0.74 95% CI 0.59, 0.93). Lymphatic reflexology was studied in too few women to draw conclusions. In conclusions, rutosides appear to relieve symptoms of venous insufficiency in late pregnancy. However, it is not known if the drug is safe in pregnancy. External pneumatic compression appears to reduce ankle swelling and compression stockings reduce leg symptoms but not varicose veins.

Capillary Fragility↗

Improvement of the walking ability in intermittent claudication due to superficial femoral artery occlusion with supervised exercise and pneumatic foot and calf compression: a randomised controlled trial.

OBJECTIVES: To compare the effect of unsupervised exercise, supervised exercise and intermittent pneumatic foot and calf compression (IPC) on the claudication distance, lower limb arterial haemodynamics and quality of life of patients with intermittent claudication. METHODS: Thirty-four eligible patients with stable intermittent claudication were randomised to IPC (n = 13, 3h/d for 6 months), supervised exercise (n = 12, three hourly sessions/week for 6 months) or unsupervised exercise (n = 9). In each patient, initial claudication distance (ICD), absolute claudication distance (ACD), resting ankle brachial pressure index (ABPI), and resting hyperaemic calf arterial inflow were measured before, 6 weeks, 6 months and 1 year after randomisation. Quality of life was assessed with the short form (SF)-36, walking impairment (WIQ) and intermittent claudication questionnaires (ICQ). RESULTS: Compared with unsupervised exercise, both IPC and supervised exercise, increased ICD and ACD, up to 2.83 times. IPC increased arterial inflow (p < 0.05 at 6 weeks) and ABPI. Supervised exercise decreased arterial inflow and increased ABPI (p < 0.05 at 6 months). Unsupervised exercise had no effect on arterial inflow or ABPI. IPC improved significantly the ICQ score and the speed score of the WIQ, while supervised exercise improved the WIQ claudication severity score. At 1 year clinical effectiveness of supervised exercise and IPC was largely preserved. CONCLUSIONS: IPC, by augmenting leg perfusion, achieved improvement in walking distance comparable with supervised exercise. Long-term results in a larger number of patients will provide valuable information on the optimal treatment modality of intermittent claudication.

Aged↗

Compression with or without early ambulation in the prevention of post-thrombotic syndrome: a systematic review.

INTRODUCTION: The aim of this study was to assess whether there is enough evidence to suggest that compression with or without early ambulation after proximal DVT reduces the risk of post-thrombotic syndrome (PTS). METHODS: Systematic review based on electronic and hand searching of the relevant literature. RESULTS: Four randomized studies were identified and despite the fact that there was lack of uniformity in reporting standards all but one showed significant risk reduction of PTS using compression. No difference in recurrent thromboembolic events (DVT or pulmonary embolism) was observed between the compression and control group. In one study the early outcome from the combination of early ambulation with compression was faster reduction of swelling with better well-being without increased risk of PE compared to the control group. Pooled analysis of all studies showed that PTS developed in 24% (61/254) in the compression group and in 46% (110/239) in the control group (chi2=25.36, p=0.0001; OR: 0.37, 95%CI: 0.25, 0.54; RR: 0.52, 95%CI: 0.40, 0.67; and RRR: 0.48, 95%CI: 0.33, 0.60) with a 48% risk reduction from the use of compression. CONCLUSION: Despite the fact that compression with or without early ambulation appears to be safe and it is more often associated with a decreased rate of PTS, the four existing studies do not permit meaningful data comparison due to lack of uniformity in reporting standards.

Bandages↗

Immediate hemodynamic effect of the additional use of the SCD EXPRESS Compression System in patients with venous ulcers treated with the four-layer compression bandaging system.

OBJECTIVES: To test the hypothesis that the SCD EXPRESS intermittent pneumatic compression applied in combination with a four-layer bandage in patients with venous ulcers increases popliteal vein volume flow and velocity. DESIGN: Twenty limbs of 18 patients with venous leg ulcers were studied, median age 76 years. The Total Volume Flow (TVF) and the Peak Systolic Velocity (PSV) were recorded in the popliteal vein using duplex ultrasonography. Measurements were made (i) without bandage, (ii) with four layer bandage and (iii) following the application of the SCD Compression System on top of a four-layer bandage for at least 15 minutes. RESULTS: The median VCSS was 17 (range, 12-22) while the median VSDS for reflux was 4.5 (range, 1-7.5). The median TVF was 71 mL/min (inter-quartile range 57-101) without bandage, 112 (IQR 89-148) with four-layer bandage and 291 (IQR 241-392) with the addition of the SCD System (P<.001, Wilcoxon signed ranks test). The median PSV was 8.4 cm/sec (IQR 6.8-14) without bandage, 13 (9.0-19) with four-layer bandage and 27 (21-31) with the addition of the SCD System (P<.001, Wilcoxon signed ranks test). Both TVF and PSV increased slightly with the addition of the four-layer bandage. However, with the addition of the SCD System these parameters increased three fold. CONCLUSIONS: The SCD EXPRESS Compression System accelerates venous flow in the legs of patients with venous ulcers already treated with a four-layer bandage. The combination of four-layer compression with the SCD System on healing venous ulcers needs to be tested by a clinical effectiveness study.

Aged↗

National survey in the United Kingdom of prophylaxis of deep vein thrombosis for patients with fracture of the neck of the femur.

Thromboprophylaxis continues to be a contentious issue because of a lack of clear answers to pertinent questions. Hence, a survey is helpful in identifying current practices. A national survey in the UK in January 2004 investigated the use of thromboprophylaxis following fracture of the neck of the femur. Responses from 723/1648 (44%) orthopaedic consultants to a postal questionnaire showed that 623 (86%) regularly undertook trauma surgery and 625 (87%) had protocols for prophylaxis of deep venous thrombosis. In all, 555 (89%) consultants followed these protocols routinely and, of these, 276 (50%) regularly used both chemical and mechanical prophylaxis, 235 (42%) used chemoprophylaxis only and 44 (8%) used mechanical prophylaxis only. Among consultants using chemoprophylaxis, 238 (46%) used low-molecular-weight heparin, 148 (30%) used aspirin, 75 (15%) used low-molecular-weight heparin and aspirin, 35 (6%) used unfractionated heparin and 15 (3%) used warfarin. However, 68 (11%) did not use any thromboprophylaxis at all for patients with fractured neck of the femur.

Femoral Neck Fractures↗

Intermittent pneumatic compression regulates expression of nitric oxide synthases in skeletal muscles.

This study investigated the effects of intermittent pneumatic compression (IPC) on expression of nitric oxide synthase (NOS) isoforms in compressed (anterior tibialis, AT) and uncompressed (cremaster muscles, CM) skeletal muscles. Following IPC application of 0.5, 1, and 5h on both legs of rats, the endothelial NOS (eNOS) mRNA expression was significantly up-regulated to 1.2-, 1.8, and 2.7-fold from normal, respectively, in both AT and CM, and protein expression increased more than 1.5-fold of normal at each time point. Similarly, neuronal NOS expression was up-regulated, but to a lesser degree. In contrast, inducible NOS expression was significantly and time-dependently down-regulated in both muscles. After IPC cessation, eNOS levels returned to normal in both AT and CM. The results confirm our hypothesis that IPC-induced vasodilation is mediated by regulating expression of NOS isoforms, in particular eNOS, in both compressed and uncompressed skeletal muscles. The results also suggest the importance of precisely characterizing expression of each NOS isoform in tissue pathophysiology.

Animals↗

Rapid foot and calf compression increases walking distance in patients with intermittent claudication: results of a randomized study.

OBJECTIVE: The aim of our pilot study was to determine the usefulness of rapid, high-pressure, intermittent pneumatic calf and foot compression (IPCFC) in patients with stable intermittent claudication, with reference to the end points of improvement in initial claudication distance (ICD) (distance at which patient feels pain or discomfort in the legs), and improvement in absolute claudication distance (ACD) (distance at which patient stops walking because the pain or discomfort becomes severe). METHODS: Thirty male patients presenting with stable, intermittent claudication (ACD between 50 and 150 meters on treadmill testing at 3.8 km/h, 10 degrees gradient) were recruited into this pilot study from a single center. Fifteen patients were randomized to treatment with IPCFC (applied for 1 hour twice daily in the sitting position) and were also advised to have daily exercise, and 15 patients served as controls, who were advised exercise alone. All patients received aspirin and had resting and postexercise ankle/brachial index (ABI) measured at enrollment along with ICD and ACD on treadmill testing (3.8 km/h, 10 degrees gradient). The mean age, baseline ICD, and ACD of the treatment and control groups were 70.4 +/- 7 years and 70.7 +/- 9 years, 55.8 +/- 15 meters and 68.4 +/- 17 meters, and 86.7 +/- 19 meters and 103.9 +/- 27 meters, respectively. Both groups were equally matched for risk factors, including smoking, type II diabetes mellitus, and hypercholesterolemia. IPCFC was applied. The study protocol included follow-up visits at 1, 2, 3, 4, 6, and 12 months with the ABI, ICD and ACD being measured at every visit. RESULTS: The percent change from baseline for ICD and ACD for each patient visit and the mean +/- standard deviation (SD), standard error (SE), and median were calculated for the control and treatment groups. The percent change from baseline measurements (mean +/- SD) for ICD and ACD in the control group at 4, 6, and 12 months were 2.2 +/- 18 and 2.3 +/- 18, 2.9 +/- 17 and 5.2 +/- 20, and 3.6 +/- 18 and 5.8 +/- 20, respectively. In contrast, the changes in ICD and ACD at 4, 6, and 12 months in the treatment group were 137.1 +/- 128 (P < .01) and 84.3 +/- 82 (P < .01), 140.6 +/- 127 (P < .01) and 96.4 +/- 106 (P = .01), and 150.8 +/- 124 (P <0.01) and 101.2 +/- 104 (P <0.01), respectively. Although the ABI showed a slight increase in the treatment group, these differences were not statistically significant. CONCLUSIONS: The results of this pilot study show that IPCFC improves walking distance in patients with stable intermittent claudication. A significant increase in ICD and ACD was seen at 4 and 6 months of treatment, respectively, and the improvement was sustained at 1 year. The combination of IPCFC with other treatment such as risk-factor modification and daily exercise may prove useful in patients with peripheral arterial occlusive disease. It may be a useful first line of therapy in patients with disabling claudication who are unfit for major reconstructive surgery. Improved walking on long-term follow-up and experience from different centers may establish a role for this treatment modality in the future.

Administration, Oral↗

Hemodynamic effects of intermittent pneumatic compression in patients with critical limb ischemia.

BACKGROUND: Traditional teaching assumes that the distal arterial tree is maximally dilated in patients with critical limb ischemia (CLI). Endovascular or arterial bypass procedures are the commonly used interventions to increase distal perfusion. However, other forms of treatment such as spinal cord stimulation or intermittent pneumatic compression (IPC) have been shown to improve limb salvage rates. This prospective study was designed to determine if the use of IPC increases popliteal, gastrocnemial, collateral arterial, and skin blood flow in patients with CLI. METHODS: Twenty limbs with CLI in 20 patients (mean age, 74 years) were evaluated with duplex ultrasound scans and laser Doppler fluxmetry in the semi-erect position before, during, and after IPC. One pneumatic cuff was applied on the foot and the other on the calf. The maximum inflation pressure was 120 mm Hg and was applied for 3 seconds at three cycles per minute. All patients had at least two-level disease by arteriography. Fourteen limbs were characterized as inoperable, and six were considered marginal for reconstruction. Flow volumes were measured in the popliteal, medial gastrocnemial, and a genicular collateral artery. Skin blood flux was measured on the dorsum of the foot at the same time. RESULTS: Significant flow increase during the application of IPC was found in all three arteries (18/20 limbs) compared with baseline values (P < .02). The highest change was seen in the popliteal, followed by the gastrocnemial and the collateral artery. After the cessation of IPC, the flow returned to baseline. This was attributed to the elevation of time average velocity, as the diameter of the arteries remained unchanged. The skin blood flux increased significantly as well (P < .03). In the two limbs without an increase in the arterial or skin blood flow, significant popliteal vein reflux was found. Both limbs were amputated shortly after. CONCLUSIONS: IPC increases axial, muscular, collateral, and skin blood flow in patients with CLI and may be beneficial to those who are not candidates for revascularization. Patients with significant venous reflux may not benefit from IPC. This supports the theory that one of the mechanisms by which IPC enhances flow is by increasing the arteriovenous pressure gradient.

Aged↗

Duration and amplitude decay of acute arterial leg inflow enhancement with intermittent pneumatic leg compression: an insight into the implicated physiologic mechanisms.

PURPOSE: By acutely enhancing the arterial leg inflow, intermittent pneumatic leg compression (IPC) improves the walking ability, arterial hemodynamics, and quality of life of claudicants. We quantified the duration of acute leg inflow enhancement with IPC of the foot (IPC(foot)), calf (IPC(calf)), or both (IPC(foot+calf)) and its amplitude decay in claudicants and controls in relation to the pulsatility index, an estimate of peripheral resistance. These findings are cross-correlated with the features of the three implicated physiologic mechanisms: (1) an increase in the arteriovenous pressure gradient, (2) suspension of peripheral sympathetic autoregulation, and (3) enhanced release of nitric oxide with flow and shear-stress increase. METHODS: Twenty-six limbs of 24 claudicants with superficial femoral artery occlusion or stenoses (>75%) and 24 limbs of 20 healthy controls matched for age and sex, meeting stringent selection criteria, had their popliteal volume flow and pulsating index (peak-to-peak velocity/mean velocity) measured with duplex scanning at rest and upon delivery of IPC. Spectral waveforms were analyzed for 50 seconds after IPC delivery per 5-second segments. The three IPC modes were applied in a true crossover design. Data analysis was performed with the Page, Friedman, Wilcoxon, Mann-Whitney and chi2 tests. RESULTS: The median duration of flow enhancement in claudicants exceeded 50 seconds with IPC(foot), IPC(calf), and IPC(foot+calf) but was shorter (P < .001) in the controls (32.5 to 40 seconds). Among the three IPC modes, the duration of flow enhancement differed (P < .05) only between IPC(foot) and IPC(foot+calf). After reaching its peak within 5 seconds of IPC, flow enhancement decayed at rates decreasing over time (trend, P < .05, Page test), which in both groups were highest at 5 to 20 seconds, moderate at 20 to 35 seconds, and lowest at 35 to 50 seconds (P < .05, Friedman test). Baseline and peak flow with all IPC modes was similar between the two groups. Pulsatility index attenuation in claudicating limbs lasted a median 32.5 seconds with IPC(foot), 37.5 seconds with IPC(calf), and 40 seconds with IPC(foot+calf); duration of pulsatility index attenuation was shorter in the control limbs with IPC(foot) (30 seconds), IPC(calf) (32.5 seconds), or IPC(foot+calf) (35 seconds), yet differences, as well as those among the 3 IPC modes, were not significant. CONCLUSION: Leg inflow enhancement with IPC exceeds 50 seconds in claudicants and lasts 32.5 to 40 seconds in the controls. Peak flow occurs concurrently with maximal pulsatility index attenuation, within 5 seconds of IPC. Irrespective of group or IPC mode, the decay rate (%) of flow enhancement is highest within 5 to 20 seconds of IPC, moderate at 20 to 35 seconds, and lowest at 35 to 50 seconds. Since attenuation in peripheral resistance terminates with the mid time period (20 to 35 seconds) of flow decay, and nitric oxide has a half-life of <7 to 10 seconds, the study's data indicate that all implicated physiologic mechanisms (1, 2, and 3) are likely active immediately after IPC delivery (0 to 20 sec) and all but nitric oxide are effective in the mid time period (20 to 35 seconds). As the pulsatility index has returned to baseline, the late phase of flow enhancement (35 to 50 seconds) could be attributable to the declining arteriovenous pressure gradient alone.

Acute Disease↗

Intermittent pneumatic compression of the foot and calf improves the outcome of catheter-directed thrombolysis using low-dose urokinase in patients with acute proximal venous thrombosis of the leg.

OBJECTIVE: Catheter-directed thrombolysis (CDT) is a promising treatment of acute proximal deep vein thrombosis (DVT) to prevent the postthrombotic syndrome by early removal of thrombus. During CDT for DVT patients, the calf muscle pump is compromised because of immobility. Intermittent pneumatic compression (IPC) can be used to increase venous flow during bed rest. The CDT with IPC may lyse venous thrombus better than CDT alone. The purpose of this study was to evaluate the efficiency and safety of IPC during CDT for DVT using low-dose urokinase. METHODS: Twenty-four patients with proximal DVT confirmed by duplex ultrasonography underwent CDT alone (10 cases) and CDT with IPC and a temporary inferior vena cava filter (14 cases) for 3 to 6 days. Pulmonary emboli (PEs) were assessed by pretreatment and posttreatment pulmonary angiogram or spiral computed tomography of the chest, and in the CDT/IPC patients, a posttreatment inferior vena cavogram was performed. The initial results were evaluated by venogram immediately after CDT, and the late results were evaluated by venous disability score and duplex ultrasonography 6 to 36 months after treatment. RESULTS: There was no symptomatic PE in either group. In CDT with IPC, one new asymptomatic PE was found, but there was no large thrombus in the inferior vena cava. The initial thrombolytic results of CDT with IPC were better than those of CDT alone (five cases of complete lysis in the CDT/IPC group and none in the CDT alone group). In the follow-up, the deep veins were patent and competent in 43% (6/14) in the CDT/IPC group, compared with 17% (1/6) in the CDT-alone group. The venous disability score showed that the CDT/IPC group had less disability than the CDT-alone group. CONCLUSIONS: This pilot study showed that adding IPC to CDT using low-dose urokinase for DVT treatment of the leg resulted in better early and late outcomes compared with CDT alone and was not associated with an increased risk of symptomatic PEs.

Acute Disease↗

The influence of inflation rate on the hematologic and hemodynamic effects of intermittent pneumatic calf compression for deep vein thrombosis prophylaxis.

OBJECTIVE: The study was conducted to determine whether the different inflation rates of intermittent pneumatic compression systems used in deep vein thrombosis prophylaxis influence their hematologic and hemodynamic effects. METHODS: A rapidly inflating intermittent calf compression system and a more gently inflating equivalent were applied to 20 healthy male volunteers for 2 hours each. Venous blood samples were taken for analysis of blood coagulation and fibrinolytic potential. Blood flow velocity was measured in the femoral vein with Doppler ultrasound. RESULTS: Tissue factor pathway inhibitor significantly increased after the 2 hours of compression for both pumps (78.0 to 85.0 ng/mL rapid, P = .004; 76.5 to 78.0 ng/mL gentle, P = .5), as did plasminogen activator activity (0.85 to 1.05 IU/mL rapid, P = .006; 0.85 to 1.5 IU/mL gentle, P = 0.5). Plasminogen activator inhibitor 1 activity was reduced, although only approaching significance for the gentle system (16.5 to 14.3 AU/mL, P = .06). A D-dimer test for global fibrinolysis showed significant increases for the gently inflating system (97 to 411 ng/mL P < .001) but not for the rapidly inflating system (276 to 350 ng/mL P = .9). The rapidly inflating system produced significantly higher venous peak velocities and augmentations as expected. CONCLUSIONS: Although the data confirm that both types of intermittent compression suppress procoagulant activation, rapid inflation clearly produced no extra benefit in increasing global fibrinolysis, and may be less hematologically effective.

Adult↗

Prevention of thrombosis with warfarin, aspirin, and mechanical methods.

Venous thromboembolism (VTE) is a serious disorder and a major cause of morbidity and mortality among acutely ill medical patients. However, despite the growing number of patients with acute medical illnesses who have an associated risk of VTE, the widespread use of VTE prophylaxis does not yet occur for both surgical and nonsurgical patients. Although individuals at greatest risk for VTE include patients undergoing major orthopedic surgery and those with medical conditions that require prolonged immobilization, all patients who have acute medical illnesses should be considered for VTE prophylaxis. Several strategies, including various mechanical and pharmacologic approaches, are currently used for VTE prophylaxis. Increased awareness about the full range of options for VTE prophylaxis can help health care providers select the appropriate course of action to help reduce the incidence of VTE among patients with acute medical illnesses.

Anticoagulants↗