Two Different Regimens of Bemiparin as a Thromboprophylaxis in Morbidly Obese Surgical Patients
Comparison of Two Different Regimens of Bemiparin as a Thromboprophylaxis After Surgery in Morbidly Obese Patients: A Randomized, Outcome-assessor Blinded Trial.
Hawler Medical University
2,400 participants
Jan 7, 2023
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria4
- 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
Exclusion Criteria7
- 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
- Unable to comply with the study treatment and/or follow-up
- Receiving prohibited medications
- Pregnancy or lactation mother
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Interventions
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 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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05569681