RecruitingNot ApplicableNCT05569681

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.


Sponsor

Hawler Medical University

Enrollment

2,400 participants

Start Date

Jan 7, 2023

Study Type

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

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study compares two different dosing schedules of bemiparin — a low-molecular-weight heparin (blood thinner used to prevent blood clots) — in very obese patients (BMI ≥ 40) who are having surgery. Standard blood thinner doses may not work as well in people with severe obesity, so this study tests whether a higher or more frequent dose gives better protection against dangerous clots. You may be eligible if: - You have a BMI of 40 or higher - You are scheduled for general, gynecological, or bariatric surgery - You are at moderate, high, or very high risk for blood clots (based on Caprini risk score) - You are willing and able to give informed consent You may NOT be eligible if: - You have active bleeding or very low platelet count - You have a history of heparin-induced thrombocytopenia (HIT) - You have severe kidney disease (GFR < 30) or severe liver disease - You have uncontrolled high blood pressure (above 200/120 mmHg) - You have a known allergy to heparin products - You were on anticoagulants within 5 days before surgery - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBemiparin 3500

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

DRUGBemiparin 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 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)

Hawler Medical university

Erbil, Kurdistan Region, Iraq

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NCT05569681


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