Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT05569681

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 90 Years

SexAll

Healthy volunteersAccepted

ConditionMorbid Obesity

Full registry criteria

Inclusion Criteria: 1. Participants required surgical intervention in: general surgery, gynecology, bariatric surgery 2. Moderate, high, and very high risk for venous thromboembolism according to Caprin RAM 3. Participant is willing and able to give informed consent for participation in the study. 4. BMI ≥40kg/m2 Exclusion Criteria: 1. 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) 2. Known hypersensitivity to unfractionated or LMWHs 3. On oral or parenteral anticoagulants within 5 days before surgery 4. Severe arterial hypertension 5. Unable to comply with the study treatment and/or follow-up 6. Receiving prohibited medications 7. Pregnancy or lactation mother

Treatments and study arms

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

Primary outcomes

Number of participants with VTE events (Deep vein thrombosis or pulmonary embolism)up to 30 days after surgery

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 )

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Hawler Medical university🌐 Erbil, Kurdistan Region, Iraq

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Nazar S. Pauls, PhDContact

Email · Call 4450611

Abubakir S. Majeed, PhDContact

Email · Call 4494656