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

Официальное название

Comparison of Two Different Regimens of Bemiparin as a Thromboprophylaxis After Surgery in Morbidly Obese Patients: A Randomized, Outcome-assessor Blinded Trial.

Обзор

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.

Подробное описание

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

Вмешательства

• Препарат 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
• Препарат 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

Первичные конечные точки

• Number of participants with VTE events (Deep vein thrombosis or pulmonary embolism) [Срок оценки: up to 30 days after surgery]

Вторичные конечные точки (1)

• Side effects of both Bemiparin doses [Срок оценки: up to 30 days after surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Ирак · 1 центр

• Hawler Medical university — Erbil

Идентификаторы

NCT: NCT05569681 · HMU4

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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