Comparison of Two Different Regimens of Bemiparin as a Thromboprophylaxis After Surgery in Morbidly Obese Patients: A Randomized, Outcome-assessor Blinded Trial.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: t
View:
• 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
Locations
Other Locations
Iraq
Hawler Medical university
RECRUITING
Erbil
Contact Information
Primary
Shahla ALALAF
shahla_alaf@yahoo.com
07504480711
Backup
Abu bakir Majeed
abubakir.majeed@hmu.edu.krd
07504494656
Time Frame
Start Date: 2023-01-07
Estimated Completion Date: 2026-04-02
Participants
Target number of participants: 2400
Treatments
Active_comparator: Bemiparin 3500 IU
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
Active_comparator: Bemiparin 5000 IU
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 patients and 30 days in very high-risk group surgical patients according to Caprinin risk classification for venous thromboembolism.~Other Name: Hibor; Laboratories Rovi Pharmaceuticals
Related Therapeutic Areas
Sponsors
Leads: Hawler Medical University