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

Sponsor

Hawler Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05569681

Collaborator

(none)

2,400

Enrollment

Location

Arms

38.8

Anticipated Duration (Months)

61.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Morbid Obesity	Drug: Bemiparin 3500 Drug: Bemiparin 5000 IU	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

2400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Two groups of orthopedic and non-orthopedic morbidly obese patients will be randomized to receive 2 different doses of BemiparinTwo groups of orthopedic and non-orthopedic morbidly obese patients will be randomized to receive 2 different doses of Bemiparin

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Local quality control approval to mask injections of Bemiparin (3500 and 5000 IU), it could not be read by the surgeon, patients, and health care provider.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 7, 2023

Anticipated Primary Completion Date :

Feb 2, 2026

Anticipated Study Completion Date :

Apr 2, 2026

Arms and Interventions

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

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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