Comparing two doses of Bemiparin for preventing blood clots in 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.
NA · Hawler Medical University · NCT05569681
This study tests whether two different doses of a blood thinner called Bemiparin can help prevent blood clots in obese patients who are having surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 2400 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Hawler Medical University (other) |
| Locations | 1 site (Erbil, Kurdistan Region) |
| Trial ID | NCT05569681 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of two different regimens of Bemiparin, a low-molecular-weight heparin, for thromboprophylaxis in morbidly obese patients undergoing various surgical procedures. Given the high risk of venous thromboembolism (VTE) in this population, the study aims to determine if adjusted doses of anticoagulants can improve VTE prevention outcomes. Participants will be monitored for VTE occurrences post-surgery to assess the efficacy of the treatment regimens. The study seeks to address the inadequacies of fixed-dose anticoagulant strategies in morbidly obese individuals.
Who should consider this trial
Good fit: Ideal candidates for this study are morbidly obese patients (BMI ≥40 kg/m²) who require surgical intervention and are at moderate to very high risk for VTE.
Not a fit: Patients with contraindications to low-molecular-weight heparins or those with severe comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of VTE in morbidly obese surgical patients, improving their postoperative outcomes.
How similar studies have performed: While there is ongoing research in VTE prophylaxis for obese patients, this specific approach using Bemiparin with adjusted dosing is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Erbil, Kurdistan Region
- Hawler Medical university — Erbil, Kurdistan Region, Iraq (RECRUITING)
Study contacts
- Principal investigator: SHAHLA ALALAF — Hawler Medical University
- Study coordinator: Shahla ALALAF
- Email: shahla_alaf@yahoo.com
- Phone: 07504480711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Morbid Obesity, LMWH, Thromboprophylaxis, Non-orthopedic surgeries, Gynecological surgeries, General surgeries, Bariatric surgeries