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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Venous Thromboembolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Enoxaparin 40 mg subcutaneous once daily

Group Type ACTIVE_COMPARATOR

Enoxaparin

Intervention Type DRUG

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

Bemiparin 3500 IU subcutaneous once daily

Group Type EXPERIMENTAL

Bemiparin

Intervention Type DRUG

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

Interventions

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Enoxaparin

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

Intervention Type DRUG

Bemiparin

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

Intervention Type DRUG

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No