Back to resultsBemiparin Versus Enoxaparin in the Prevention of Venous Thromboembolism Among ICU Patients
Primary Purpose
Venous Thromboembolism
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Enoxaparin
Bemiparin
Sponsored by
About this trial
This is an interventional treatment trial for Venous Thromboembolism
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Enoxaparin 40 mg subcutaneous once daily
Bemiparin 3500 IU subcutaneous once daily
Arm Description
Outcomes
Primary Outcome Measures
Development of deep venous thrombosis
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
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02795065
Brief Title
Bemiparin Versus Enoxaparin in the Prevention of Venous Thromboembolism Among ICU Patients
Official Title
Bemiparin Versus Enoxaparin in the Prevention of Venous Thromboembolism Among ICU Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohamed Sayed Mohamed Abbas
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enoxaparin 40 mg subcutaneous once daily
Arm Type
Active Comparator
Arm Title
Bemiparin 3500 IU subcutaneous once daily
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Intervention Description
Use of enoxaparin 40 mg subcutaneous once daily in high risk intensive care patients as a prophylaxis against venous thromboembolism
Intervention Type
Drug
Intervention Name(s)
Bemiparin
Intervention Description
Use of bemiparin 3500 IU subcutaneous once daily in high risk intensive care patients as a prophylaxis against venous thromboembolism
Primary Outcome Measure Information:
Title
Development of deep venous thrombosis
Description
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
Time Frame
Within 2 years
Title
Development of pulmonary embolism
Description
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
Time Frame
Within 2 years
Title
Complications related to the injected anticoagulant
Description
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.
Time Frame
Within 2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
12871445
Citation
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.
Results Reference
background
PubMed Identifier
28808360
Citation
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.
Results Reference
derived
Learn more about this trial
Bemiparin Versus Enoxaparin in the Prevention of Venous Thromboembolism Among ICU Patients
We'll reach out to this number within 24 hrs