Clinical trial

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

Name

HMU4

Description

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.

Trial arms

Trial start

2023-01-07

Estimated PCD

2026-02-02

Trial end

2026-04-02

Status

Recruiting

Treatment

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

Arms:

Bemiparin 3500 IU

Other names:

Hibor 3500 IU

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

Arms:

Bemiparin 5000 IU

Other names:

Hibor 5000 IU

Size

2400

Primary endpoint

Number of participants with VTE events (Deep vein thrombosis or pulmonary embolism)

up to 30 days after surgery

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups of orthopedic and non-orthopedic morbidly obese patients will be randomized to receive 2 different doses of Bemiparin', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 2400, 'type': 'ESTIMATED'}}

Updated at

2024-02-13

1 organization

1 product

1 indication

Organization

Hawler Medical University

Product

Bemiparin

Indication

Severe Obesity