About this trial
Morbid obesity, is known to be associated with a high risk of VTE and, unfortunately, fixed doses of anticoagulant regimens may not provide optimal VTE prophylaxis in these patients especially after surgery.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participants required surgical intervention in: general surgery, gynecology, bariatric surgery
Moderate, high, and very high risk for venous thromboembolism according to Caprin RAM
Participant is willing and able to give informed consent for participation in the study.
BMI ≥40kg/m2
Disqualifiers
Having any contraindication to LMWH, such as active bleeding, history of heparin-induced thrombocytopenia , baseline platelet count <75 × 108/μl, severe renal disease (glomerular filtration rate <30 ml/minute), severe liver disease, or uncontrolled hypertension (>200/120 mmHg)
Known hypersensitivity to unfractionated or LMWHs
On oral or parenteral anticoagulants within 5 days before surgery
Severe arterial hypertension
Trial design
Parallel
Treatments tested in this trial
Bemiparin 3500
DrugBemiparin sodium 3,500 IU anti Xa/0.2 ml solution for injection in the pre-filled syringe will be provided for each patient in one group; subcutaneously 6 hours after the surgery(orthopedic and non-orthopedic) and then daily for up to 10 days for moderate and high - risk group and for 30 days in very high risk-group patients according to Caprinin risk classification for venous thromboembolism. Other Name: Hibor; Laboratories Rovi Pharmaceuticals
Bemiparin 5000 IU
DrugBemiparin sodium 5000 IU anti Xa/0.2 ml solution for injection in the pre-filled syringe will be provided for each patient in one group; subcutaneously 6 hours after the surgery(orthopedic and non-orthopedic) and then daily for up to 10 days for moderate and high - risk group and for 30 days in very high risk-group patients according to Caprinin risk classification for venous thromboembolism. Other Name: Hibor; Laboratories Rovi Pharmaceuticals
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with VTE events (Deep vein thrombosis or pulmonary embolism)
Deep vein thrombosis or pulmonary embolism will be confirmed by objective methods (Compression duplex ultrasound for deep vein thrombosis; perfusion/ventilation lung for pulmonary embolism )
Secondary outcomes
Side effects of both Bemiparin doses
Major bleedings,minor bleedings ,total bleeding events (major + minor),thrombocytopenia,injection site reactions, serious adverse events,discontinuations due to adverse side effects
Sponsors and contacts
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