Bemiparin Versus Enoxaparin in the Prevention of Venous Thromboembolism Among ICU Patients

The purpose of this study is to compare two types of low-molecular-weight heparin, enoxaparin and bemiparin, as regards their efficacy and safety in venous thromboembolism prevention among intensive care unit patients.

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

A prospective randomized trial to compare thromboprophylaxis using bemiparin and enoxaparin in critically ill patients in ICU. The study included one hundred bedridden patients in intensive care unit who are at high risk for developing venous thromboembolism and require long term anticoagulation

Patients were divided into two groups each one consists of 50 patients. One group received bemiparin 3500 IU subcutaneous once daily and the other group received enoxaparin 40 mg subcutaneous once daily as a prophylaxis against thromboembolism.

Patients were followed up for 60 days for the development of deep venous thrombosis, pulmonary embolism and complications related to the injected anticoagulant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Sepsis , stroke , major burn , respiratory failure , traumatic brain injury , malignancy and post arrest who are intubated and mechanically ventilated on continuous IV sedation

Exclusion criteria

Hypersensitivity to low molecular weight heparins , hypercoagulability , congenital or acquired bleeding disorder, prolongation of activated partial thromboplastin time or prothrombin time by 20% compared to normal values; thrombocytopenia (platelet count <100,000/mm3); macroscopic hematuria; uncontrolled hypertension [systolic blood pressure >200 mmHg; diastolic blood pressure >100 mmHg]; impaired kidney function: serum creatinine > 2.0 mg/ dL and bleeding gastrointestinal ulcer.

Treatment and study plan

Enoxaparin

Drug

Use of enoxaparin 40 mg subcutaneous once daily in high risk intensive care patients as a prophylaxis against venous thromboembolism

Bemiparin

Drug

Use of bemiparin 3500 IU subcutaneous once daily in high risk intensive care patients as a prophylaxis against venous thromboembolism

Primary outcomes

Development of deep venous thrombosis

Time frame: Within 2 years

Deep venous thrombosis was detected using bilateral lower limb venous duplex done twice weekly over the period of 60 days or if patient had clinical symptoms of deep venous thrombosis during hospitalization. Best evaluation of Different lower extremities veins is obtained by using different ultrasound techniques. Proximal deep veins, specifically the common femoral, femoral, and popliteal veins are usually examined using compression ultrasound whereas a combination of duplex ultrasound and color Doppler imaging is more often used to interrogate the calf and iliac veins
Development of pulmonary embolism

Time frame: Within 2 years

Pulmonary embolism was detected clinically by hypotension, tachycardia, hypoxemia, and decreased end-tidal carbondioxide and confirmed radiologically by CT pulmonary angiography if there was arterial occlusion with failure to enhance the entire lumen due to a large filling defect , a partial filling defect surrounded by contrast material or a peripheral intraluminal filling defect that forms acute angles with the arterial wall
Complications related to the injected anticoagulant

Time frame: Within 2 years

Patient were followed up daily for complications related to the injected anticoagulant including any ecchymosis or hematomas developed at the site of anticoagulant injection , the presence of major bleeding defined as decrease in hemoglobin levels by 2 gm/L or more or requiring transfusion of 2 or more units of packed red cells or whole blood, the presence of minor bleeding defined as any bleeding other than major bleeding events , drop in the platelet count and the presence of allergic skin reactions or urticaria, If any of these complications was observed , the anticoagulant was immediately discontinued.

Sponsors and collaborators

Lead sponsor

Mohamed Sayed Mohamed Abbas

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Jun 9, 2016
Registry last updated: Jun 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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