Comparison of Two Different Regimens of Bemiparin as a Thromboprophylaxis After Surgery in Morbidly Obese Patients: A Randomized, Outcome-assessor Blinded Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,400
- 试验地点
- 2
- 主要终点
- Number of participants with VTE events (Deep vein thrombosis or pulmonary embolism)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None (Participant, Care Provider, Investigator)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Bemiparin 3500 (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 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
干预措施: Bemiparin 5000 IU (Drug)
结局指标
主要结局
Number of participants with VTE events (Deep vein thrombosis or pulmonary embolism)
时间窗: 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 )
次要结局
- Side effects of both Bemiparin doses(up to 30 days after surgery)
研究者
SHAHLA KAREEM ALALAF
Professor
Hawler Medical University