Comparison Between the Efficacy of Rivaroxaban vs Enoxaparin in Post-Operative Deep Venous Thrombosis Prophylaxis After Exploratory Laparotomy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Incidence of Deep Vein Thrombosis (DVT)
研究概览
简要总结
The goal of this clinical trial is to learn if rivaroxaban works better than enoxaparin to prevent deep vein thrombosis (DVT) after emergency exploratory laparotomy in adults. It will also learn about the safety of rivaroxaban compared to enoxaparin.
The main questions it aims to answer are:
Does rivaroxaban lower the number of patients who develop DVT after exploratory laparotomy compared to enoxaparin?
What medical problems or side effects do participants have when taking rivaroxaban versus enoxaparin?
Researchers will compare rivaroxaban (an oral anticoagulant) to enoxaparin (a subcutaneous injection) to see which drug works better to prevent blood clots after surgery.
Participants will:
Take rivaroxaban 10 mg orally once daily for 7 days, or enoxaparin 40 mg subcutaneously once daily for 7 days after surgery
Undergo duplex color Doppler ultrasound scans of the legs on day 5 and day 10 after surgery
Be monitored for bleeding, complications, and other side effects
详细描述
Postoperative venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), is a major and preventable cause of morbidity and mortality after surgery. Patients undergoing emergency exploratory laparotomy are at especially high risk due to prolonged operative times, systemic inflammation, and immobility. While low-molecular-weight heparins (LMWH), such as enoxaparin, are the current standard for prophylaxis, direct oral anticoagulants such as rivaroxaban offer potential advantages in terms of ease of administration, compliance, and patient comfort.
This randomized controlled trial was designed to compare the efficacy and safety of once-daily oral rivaroxaban (10 mg) with once-daily subcutaneous enoxaparin (40 mg) in preventing postoperative DVT in adult patients undergoing emergency exploratory laparotomy at Mayo Hospital, Lahore.
Eligible patients were adults aged 18-80 years undergoing emergency laparotomy for traumatic or non-traumatic indications and expected to remain immobile for more than 24 hours postoperatively. Patients with pre-existing DVT, morbid obesity (BMI ≥40), active bleeding risk, mechanical ventilation, myocardial infarction, cerebrovascular accident, or current anticoagulation therapy were excluded.
Participants were randomized using a computer-generated sequence with allocation concealment. Rivaroxaban or enoxaparin was given for 7 days postoperatively, in addition to standard perioperative care and mechanical prophylaxis.
The primary outcome was the incidence of DVT as confirmed by duplex color Doppler ultrasound on postoperative days 5 and 10. Any noncompressible or indistinct venous segment was scored as positive for DVT. Wells scores were also recorded to stratify risk.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 80 years
- •Both male or female patients
- •Patients who have undergone emergent exploratory laparotomy for any reason whether traumatic or non-traumatic
- •Patients with expected immobility for more than 24 hours
排除标准
- •Patients with diagnosed pre-operative DVT
- •BMI more than 40
- •Patient who are on mechanical ventilation post operatively
- •Patient with postoperative Myocardial infarction, ischemic heart disease or cerebrovascular accident
- •Patients who have undergone limb surgery in addition to exploratory laparotomy
研究组 & 干预措施
Rivaroxaban Group
Arm 1 Title: Rivaroxaban Group Arm Type: Experimental Intervention Name: Drug: Rivaroxaban Descri
干预措施: rivaroxaban (10mg) (Drug)
Enoxaparin Group
Arm 2 Title: Enoxaparin Group
Arm Type: Active Comparator
Intervention Name: Drug: Enoxaparin
Description: Participants receive enoxaparin 40 mg subcutaneously once daily for 7 days after emergency exploratory laparotomy, in addition to standard perioperative care and mechanical prophylaxis.
干预措施: Enoxaparin 40 mg SC (Drug)
结局指标
主要结局
Incidence of Deep Vein Thrombosis (DVT)
时间窗: Postoperative Day 5 and Day 10
Presence of DVT in the lower limbs will be assessed by duplex color Doppler ultrasonography on postoperative day 5 and day 10. A noncompressible or indistinct venous segment on ultrasound will be considered positive for DVT. The outcome will be reported as the proportion of participants in each treatment arm who develop DVT.
次要结局
未报告次要终点
研究者
Muhammad Mashhood Ahmad Shad
Principle Investigator
Mayo Hospital Lahore