Timing of Venous Thromboembolism Prophylaxis in Traumatic Brain Injury
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- VTE
研究概览
简要总结
This study compares the efficacy and complication rates of early (24 hours) versus late (72 hours) VTE prophylaxis administration to TBI patients. Patients in both treatment groups will be monitored for development of VTE as well as complications from bleeding after commencement of VTE prophylaxis.
详细描述
This a randomized prospective study that compares the efficacy and complication rates of early (24 hours) versus late (72 hours) VTE prophylaxis administration to TBI patients. Patients who are identified as having an intracranial injury will be randomized to early versus late VTE prophylaxis using a 1:1 random numbers allocation. Patients in both treatment groups will be monitored for development of VTE, primarily with scheduled duplex ultrasound studies of the lower extremities. Any clinical suspicion of VTE will also be investigated with duplex ultrasound and/or CT angiogram of the chest. Patients will be monitored for development of complications from bleeding post commencement of VTE prophylaxis. Intracranial bleeding complications will be monitored by physical examination and CT scanning of the head when indicated. Patients who undergo craniotomy or craniectomy will have VTE prophylaxis started 72 hours post-surgery and will undergo CT scan of the head (to assure bleeding stabilization) prior to administration of VTE prophylaxis.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Traumatic brain injury
- •Intracranial hemorrhage on CT scan
排除标准
- •Under the age of 18
- •Die within 24 hours of admission
- •Hospital stay less than 5 days
- •Contraindications to enoxaparin or heparin
- •Coagulopathy at 24 hours post-injury defined as INR>1.6 aPTT>2x normal, or platelet counts<50k
- •Known history of VTE
研究组 & 干预措施
Late (72 hours)
Patients will receive VTE prophylaxis (heparin 5000 U q 8 hrs or enoxaparin 30 mg q 12 hrs) 72 hours after injury if CT head is stable.
干预措施: Enoxaparin Sodium 150 MG/ML Prefilled Syringe (Drug)
Early (24 hours)
Patients will receive VTE prophylaxis (heparin 5000 U q 8 hrs or enoxaparin 30 mg q 12 hrs) 24 hours after injury if CT head is stable.
干预措施: Enoxaparin Sodium 150 MG/ML Prefilled Syringe (Drug)
Early (24 hours)
Patients will receive VTE prophylaxis (heparin 5000 U q 8 hrs or enoxaparin 30 mg q 12 hrs) 24 hours after injury if CT head is stable.
干预措施: Heparin (Drug)
Late (72 hours)
Patients will receive VTE prophylaxis (heparin 5000 U q 8 hrs or enoxaparin 30 mg q 12 hrs) 72 hours after injury if CT head is stable.
干预措施: Heparin (Drug)
结局指标
主要结局
VTE
时间窗: Outcomes will be assessed until hospital discharge. Data will be presented at study completion with the expectation of approximately 2 years.
Rate of venous thromboembolism (DVT or PE)
次要结局
- Bleeding complications(Outcomes will be assessed until hospital discharge. Data will be presented at study completion with the expectation of approximately 2 years.)
研究者
Michael Anstadt
Assistant Professor of Surgery
Loyola University