CTRI/2022/12/048107尚未招募2/3 期
Randomised Control Trial to Compare efficacy of Dabigatran versus Aspirin in Prevention of Venous Thromboembolism in Pelvic and Acetabular injuries
Chinmoy Sharma1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年12月20日最近更新:
适应症
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Primary/Main outcome - The incidence of Deep vein thrombosis in patients treated with eithe Dabigatran or Aspirin
研究概览
简要总结
AIM OF STUDY
To assess and compare the efficacy and safety of Dabigatran and Aspirin in prevention of Venous Thromboembolism in Pelvic and Acetabular injuries
OBJECTIVES
1. To compare the effectiveness of Dabigatran and Aspirin in preventing Symptomatic or Asymptomatic Deep vein Thrombosis .
2. To compare the safety of Dabigatran and Aspirin in terms of major post-surgical haemorrhage.
Hypothesis - Dabigatran is more effective than aspirin in preventing Thromboembolism
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with Pelvic and Acetabular fractures above 18 years of age, treated surgically or conservatively and requiring 6 weeks or more of immobilization will be included in the study.
排除标准
- •Patients below 18 years of age
- •Patients with open injuries of the lower limb requiring external fixators/soft tissue cover in the form of grafts/flaps which precludes compression stockings application will be excluded.
- •Patients with Bilateral/contralateral lower limb injuries
- •Patients with concomitant head/ abdominal injury requiring intervention
- •Patients with previous history of Venous Thromboembolism, coagulopathies, malignancy,
- •Patients with Impaired Kidney function
- •Patients with previous non ambulatory status,
- •Patients on anticoagulant therapy
- •Patients who do not consent for the study will be excluded
- •Patients lost to follow up will be excluded.
结局指标
主要结局
Primary/Main outcome - The incidence of Deep vein thrombosis in patients treated with eithe Dabigatran or Aspirin
时间窗: DVT will be assessed by venous doppler at 6 weeks and 12 weeks from date of surgery or date of trauma( if treated conservatively)
次要结局
- The secondary outcome would be the incidence of major bleeding events in either of the two categories. Major bleeding events means the requirement of surgical intervention(Major bleeding event would normally follow up at our hospital. Or else it will be assessed at 6 weeks and 12 weeks follow up if managed in other hospitals)
研究者
研究点 (1)
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