- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02795065
Bemiparin Versus Enoxaparin in the Prevention of Venous Thromboembolism Among ICU Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Enoxaparin 40 mg subcutaneous once daily
|
Use of enoxaparin 40 mg subcutaneous once daily in high risk intensive care patients as a prophylaxis against venous thromboembolism
|
Experimental: Bemiparin 3500 IU subcutaneous once daily
|
Use of bemiparin 3500 IU subcutaneous once daily in high risk intensive care patients as a prophylaxis against venous thromboembolism
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Within 2 years
|
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
|
Within 2 years
|
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.
|
Within 2 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Navarro-Quilis A, Castellet E, Rocha E, Paz-Jimenez J, Planes A; Bemiparin Study Group in Knee Arthroplasty. Efficacy and safety of bemiparin compared with enoxaparin in the prevention of venous thromboembolism after total knee arthroplasty: a randomized, double-blind clinical trial. J Thromb Haemost. 2003 Mar;1(3):425-32. doi: 10.1046/j.1538-7836.2003.00142.x.
- Abbas MS. Bemiparin versus Enoxaparin in the Prevention of Venous Thromboembolism among Intensive Care Unit Patients. Indian J Crit Care Med. 2017 Jul;21(7):419-423. doi: 10.4103/ijccm.IJCCM_23_17.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSAT-4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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