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

NCT05569681 | Recruiting

• 1 other identifier: HMU4
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity

Keywords

LMWH; Thromboprophylaxis; Non-orthopedic surgeries; Gynecological surgeries; General surgeries; Bariatric surgeries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Side effects of both Bemiparin doses

  up to 30 days after surgery

Study Arms (2)

Bemiparin 3500 IU

ACTIVE COMPARATOR

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 5000 IU

ACTIVE COMPARATOR

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

Interventions

Bemiparin 3500 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

Also known as: Hibor 3500 IU

Bemiparin 3500 IU

Bemiparin 5000 IU 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

Also known as: Hibor 5000 IU

Bemiparin 5000 IU

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants required surgical intervention in: general surgery, gynecology, bariatric surgery
• Moderate, high, and very high risk for venous thromboembolism according to Caprin RAM
• Participant is willing and able to give informed consent for participation in the study.
• BMI ≥40kg/m2

You may not qualify if:

• 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)
• Known hypersensitivity to unfractionated or LMWHs
• On oral or parenteral anticoagulants within 5 days before surgery
• Severe arterial hypertension
• Unable to comply with the study treatment and/or follow-up
• Receiving prohibited medications
• Pregnancy or lactation mother

Sponsors & Collaborators

• Hawler Medical University: lead

Study Sites (1)

Hawler Medical university

Erbil, Kurdistan Region, 44001, Iraq

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid

Interventions

bemiparin

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• SHAHLA ALALAF

  Hawler Medical University

  PRINCIPAL INVESTIGATOR

• Ariana Jawad

  Kurdistan Higher Counsel of Medical Specialties

  STUDY CHAIR

• Abdulkader Alany

  Hawler Medial University

  STUDY DIRECTOR

• Ali Al-Dabbagh

  Hawler Medical University

  STUDY CHAIR

Central Study Contacts

Shahla ALALAF

CONTACT

07504480711; shahla_alaf@yahoo.com

Abu bakir Majeed

CONTACT

07504494656; abubakir.majeed@hmu.edu.krd

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: outcome-assessor blinded study. Due to inherent color differences between the two types of LMWH, the treatment administration could not be fully masked. However, treatment allocation was masked from the outcome assessor from the start by using coded envelopes
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Postsurgical morbidly obese patients will be randomized to receive 2 different doses of Bemiparin

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 6, 2022
• Study Start: January 7, 2023
• Primary Completion (Estimated): September 2, 2026
• Study Completion (Estimated): October 2, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

IR (1)