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

NCT02795065 | Completed

• 1 other identifier: MSAT-4
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (3)

• 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

  Within 2 years

• 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

  Within 2 years

• 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.

  Within 2 years

Study Arms (2)

Enoxaparin 40 mg subcutaneous once daily

ACTIVE COMPARATOR

Drug: Enoxaparin

Bemiparin 3500 IU subcutaneous once daily

EXPERIMENTAL

Drug: Bemiparin

Interventions

Enoxaparin DRUG

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

Enoxaparin 40 mg subcutaneous once daily

Bemiparin DRUG

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

Bemiparin 3500 IU subcutaneous once daily

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mohamed Sayed Mohamed Abbas: lead

Related Publications (2)

• 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.

  PMID: 12871445 BACKGROUND

• 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.

  PMID: 28808360 DERIVED

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Enoxaparin; bemiparin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: June 9, 2016
• Study Start: March 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: June 10, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share