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

Morbid Obesity Clinical Trial

Official title:

Comparison of Two Different Regimens of Bemiparin as a Thromboprophylaxis After Surgery in Morbidly Obese Patients: A Randomized, Double Blind Multicenter Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05569681
• Other study ID #: HMU4
• Status: Recruiting
• Phase: N/A
• Start date: January 7, 2023
• Est. completion date: April 2, 2026

Study information

• Verified date: February 2024
• Source: Hawler Medical University
• Contact: Shahla ALALAF
• Phone: 07504480711
• Email: shahla_alaf[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2400
• Est. completion date: April 2, 2026
• Est. primary completion date: February 2, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Participants required surgical intervention in: general surgery, orthopedic, neurosurgery, 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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

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
• 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

Locations

Country	Name	City	State
Iraq	Hawler Medical university	Erbil	Kurdistan Region

Sponsors (1)

Lead Sponsor	Collaborator
Hawler Medical University

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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