OPTTICH Pilot Study - OPtimal Timing of Thromboprophylaxis in Traumatic IntraCranial Haemorrhage
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Proximal lower limb deep vein thrombosis (DVT) diagnosed by bilateral lower extremity compression ultrasound (US).
研究概览
简要总结
Victims of trauma with severe head injury who have bled into their brains are at high risk of developing blood clots in their legs. These blood clots can break off and travel through the bloodstream to the lungs, resulting in death. Blood thinners can be given to patients to prevent blood clots from developing but this can leave patients at risk for additional bleeding in the brain, causing further damage or death. The earlier blood thinners are started, the more effective they are at preventing blood clots. In addition, some patients with severe head injury who have bled into their brains will develop further bleeding even if they do not receive blood thinners. Even though a growing body of research has shown that the majority of bleeding in the brain stops within the first 24 hours after injury and that it is safe to start blood thinners as early as 24 hours after injury, doctors are still waiting longer than 4 days to start blood thinners in these patients over concerns of worsening bleeding. In Canada, almost half of the patients with severe head injury do not receive blood thinners until at least five days after injury. Delays in starting blood thinners appear to put patients at increased risk of developing blood clots, unnecessarily. This study will compare the benefits of starting low-molecular-weight heparin (LMWH), a type of blood thinner, early (36 to 48 hours after injury) versus the current practice (waiting until the 6th day after being injured) in preventing blood clots in patients who have bled into their brains after severe head injury. The investigators believe that starting LMWH earlier will be more effective in preventing blood clots without worsening any bleeding when compared to waiting to start blood thinners. This study is called OPTTICH (OPtimal timing of Thromboprophylaxis in Traumatic IntraCranial Haemorrhage) and will be the largest Canadian investigator-initiated randomized control trial on blood clot prevention in trauma patients with severe head injury who have bled into their brains.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multi-system trauma patients referred to the trauma service with a non-progressing tICH documented on 24-hour repeat head CT scan
排除标准
- •Unexpected to survive or remain in hospital >72 hours
- •Known malignancy under active care at time of admission
- •Known DVT, PE or other condition requiring anticoagulation at time of admission
- •Coagulopathy (defined as international normalized ratio (INR) values >1.5 times the upper limit of normal, or partial thromboplastin time (PTT) values >1.5 times the upper limit of normal) at 24 hours after admission
- •Platelet count <75 x 10^9/L at 24 hours after admission
- •Bilateral lower limb amputation
- •History of allergy to heparin or suspected or proven HIT
- •Limitation of life support or palliative care
- •Prior enrollment in this trial or currently in a confounding randomized trial
- •Pregnancy
- •Study drug (LMWH or placebo) not administered within 36-48 hours post-injury
- •Grade V liver or splenic injuries that have not received definitive care (e.g. embolization, surgical intervention) within 36-48 hours after injury
- •Persistent intracranial pressure >20 mm Hg
- •Spinal subdural haematoma or spinal epidural haematoma
- •Intracranial haemorrhage progression on 24-hour repeat CT scan
研究组 & 干预措施
Early initiation of thromboprophylaxis
Early initiation of thromboprophylaxis with Enoxaparin between 36-48 hours post-injury until day 5, followed by standard of care (DVT prophylaxis with Enoxaparin) starting on post-injury day 6.
干预措施: Enoxaparin (Drug)
Late initiation of thromboprophylaxis
Initiation of placebo (normal saline) 36-48 hours post-injury until day 5, followed by standard of care (DVT prophylaxis with Enoxaparin) starting on post-injury day 6.
干预措施: Placebo (Other)
结局指标
主要结局
Proximal lower limb deep vein thrombosis (DVT) diagnosed by bilateral lower extremity compression ultrasound (US).
时间窗: Maximum of 60 days or until hospital discharge.
Ultrasounds will be performed within 72 hours of enrollment as well as twice weekly when in ICU and weekly thereafter. Non-compressibility of 1 or more proximal deep venous segments on compression US will be considered diagnostic. Each segment will be assessed as fully compressible, partially compressible, not compressible, or not well-visualized. All positive US will be recorded and stratified into above-knee (proximal DVT) or below-knee (distal DVT). Patients who have both proximal and distal DVT will be classified as having proximal DVT.
次要结局
- Intracranial haemorrhage progression (IHP)(Maximum of 60 days or until hospital discharge.)
- Non-intracranial bleeding(Maximum of 60 days or until hospital discharge.)
- Pulmonary Embolism (PE)(Maximum of 60 days or until hospital discharge.)
研究者
Niv Sne
Dr. Niv Sne, Director of Trauma Research
McMaster University