Two Different Regimens of Bemiparin as a Thromboprophylaxis in Morbidly Obese Surgical Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorHawler Medical University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Bemiparin 3500

    Drug

    Bemiparin 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

    Drug

    Bemiparin 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

2,400 Participants
are divided into 2 treatment groups
Group A: Bemiparin 3500 IUActive comparator 1 intervention
Group B: Bemiparin 5000 IUActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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 )

Time frame
up to 30 days after surgery

Secondary outcomes

1

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

Time frame
up to 30 days after surgery

Other outcomes

Sponsors and contacts

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