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.

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.

Study Overview

• Status: Recruiting
• Conditions: Morbid Obesity
• Intervention / Treatment: Drug: Bemiparin 3500; Drug: Bemiparin 5000 IU

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.

Rationale for Change: Due to challenges in recruiting orthopedic surgical patients within the study timeframe, the protocol has been amended to exclude this patient population. This change ensures the study can proceed with a feasible sample size while maintaining the integrity of the research question regarding LMWH thromboprophylaxis in non-orthopedic surgical patients with morbid obesity. This amendment will not alter the primary research question regarding the efficacy and safety of two doses of LMWH thromboprophylaxis. However, it will narrow the scope of the study to focus exclusively on non-orthopedic surgical patients

• Study Type: Interventional
• Enrollment (Estimated): 2400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shahla ALALAF; Phone Number: 00964 07504480711; Email: shahla_alaf@yahoo.com
• Study Contact Backup: Name: Abu bakir Majeed; Phone Number: 00964 07504494656; Email: abubakir.majeed@hmu.edu.krd

Study Locations

• Iraq
  • Kurdistan Region
    • Erbil, Kurdistan Region, Iraq, 44001
      • Recruiting
      • Hawler Medical University
      • Contact: Nazar S. Pauls, PhD; Phone Number: 00964750 4450611; Email: nazarpauls@yahoo.com
      • Contact: Abubakir S. Majeed, PhD; Phone Number: 00964750 4494656; Email: info@zjms.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: 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; Other Names: Hibor 3500 IU
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	Drug: 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 and for 30 days in very high risk-group patients according to Caprinin risk classification for venous thromboembolism. Other Name: Hibor; Laboratories Rovi Pharmaceuticals; Other Names: Hibor 5000 IU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with VTE events (Deep vein thrombosis or pulmonary embolism)	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 )	up to 30 days after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hawler Medical University
• Investigators: Principal Investigator: SHAHLA ALALAF, Hawler Medical University; Study Chair: Ariana Jawad, Kurdistan Higher Counsel of Medical Specialties; Study Director: Abdulkader Alany, Hawler Medial University; Study Chair: Ali Al-Dabbagh, Hawler Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2023
• Primary Completion (Estimated): September 2, 2026
• Study Completion (Estimated): October 2, 2026

Study Registration Dates

• First Submitted: October 3, 2022
• First Submitted That Met QC Criteria: October 5, 2022
• First Posted (Actual): October 6, 2022

Study Record Updates

• Last Update Posted (Estimated): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Thromboprophylaxis; LMWH; Non-orthopedic surgeries; Bariatric surgeries; Gynecological surgeries; General surgeries
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity, Morbid; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Fibrinolytic Agents; Anticoagulants; bemiparin
• Other Study ID Numbers: HMU4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No