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

NCT ID: NCT05569681

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-07
• Study Completion Date: 2026-10-02

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.

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

Conditions

Morbid Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Bemiparin 3500

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

Bemiparin 5000 IU

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Hibor 3500 IU; Hibor 5000 IU

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hawler Medical University

OTHER

Sponsor Role: lead

Responsible Party

SHAHLA KAREEM ALALAF

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SHAHLA ALALAF

Role: PRINCIPAL_INVESTIGATOR

Hawler Medical University

Ariana Jawad

Role: STUDY_CHAIR

Kurdistan Higher Counsel of Medical Specialties

Abdulkader Alany

Role: STUDY_DIRECTOR

Hawler Medial University

Ali Al-Dabbagh

Role: STUDY_CHAIR

Hawler Medical University

Locations

Hawler Medical university

Erbil, Kurdistan Region, Iraq

Site Status: RECRUITING

Countries

Iraq

Central Contacts

Shahla ALALAF

Role: CONTACT

shahla_alaf@yahoo.com

07504480711 ext. 00964

Abu bakir Majeed

Role: CONTACT

abubakir.majeed@hmu.edu.krd

07504494656 ext. 00964

Facility Contacts

Nazar S. Pauls, PhD

Role: primary

nazarpauls@yahoo.com

4450611 ext. 00964750

Abubakir S. Majeed, PhD

Role: backup

info@zjms.org

4494656 ext. 00964750

Other Identifiers

HMU4

Identifier Type: -

Identifier Source: org_study_id