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

Not Applicable

Recruiting

• Conditions: Morbid Obesity
• Interventions: Drug: Bemiparin 5000 IU; Drug: Bemiparin 3500

• Registration Number: NCT05569681
• Lead Sponsor: Hawler Medical University

Brief 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.

Detailed Description

Venous thromboembolism (VTE) is serious and preventable in patients who have undergone recent surgery . Most surgical patients are required to receive VTE prophylaxis, usually pharmacologic prophylaxis. Notwithstanding, rates of appropriate perioperative thromboprophylaxis remain tenaciously low, although the expansion of quality-improvement efforts has led to widespread hospital implementation of prophylaxis strategies.

Obesity, including morbid obesity, is known to be associated with a high risk of VTE and, unfortunately, fixed doses of anticoagulant regimens (unfractionated heparins, low-molecular-weight heparins, and factor Xa inhibitors) may not provide optimal VTE prophylaxis in these patients especially after surgery. Cumulative evidence and works of the literature suggest that anticoagulant dose adjustments in morbidly obese patients may reduce VTE risk. With the increasing rate of morbid obesity, more high-quality clinical trials are needed to prevent VTE in morbidly obese surgical patients providing effective, safe, prevention strategies

Study Timeline

• Study First Submitted: 2022-10-03
• Study First Submitted QC: 2022-10-05
• Study First Posted: 2022-10-06
• Study Start: 2023-01-07
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-08
• Last Update Posted: 2025-03-11
• Primary Completion: 2026-02-02
• Study Completion: 2026-04-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bemiparin 5000 IU	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
Bemiparin 3500 IU	Bemiparin 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

Primary Outcome Measures

Name	Time	Method
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 )

Secondary Outcome Measures

Name	Time	Method
Side effects of both Bemiparin doses	up to 30 days after surgery	Major bleedings,minor bleedings ,total bleeding events (major + minor),thrombocytopenia,injection site reactions, serious adverse events,discontinuations due to adverse side effects

Trial Locations

Locations (1)

Hawler Medical university; 🇮🇶 Erbil, Kurdistan Region, Iraq