PROphylaxis for venous ThromboEmbolism in severe Traumatic brain injury (the PROTEST RCT)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 1. Symptomatic, objectively-confirmed PE.
研究概览
简要总结
Authorship on study publications will adhere to the Uniform Requirements for Manuscripts Submitted to Biomedical Journals of the International Committee of Medical Journal Editors. These Requirements state “Authorship credit should be based on:
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Substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data;
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Drafting the article or revising it critically for important intellectual content; and
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Final approval of the version to be published.
Authors should meet conditions 1, 2, and 3. Where journal policies permit, all study site investigators who played a contributing role in the trial, including to its accrual, will be included in an Acknowledgement section.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with severe and moderate acute TBI defined as: a.
- •GCS of ≤8 or b.
- •GCS of 9-12 (moderate) with any intracranial hemorrhage seen on CT scan (patients with only subarachnoid hemorrhage are excluded) ii) Upon randomization patient can receive the first dose of study drug in the first 3 calendar days of the time of injury (within 72 hours after injury).
- •ii) ≥ 18 years of age.
排除标准
- •All participants meeting any of the following exclusion criteria at baseline will be excluded from participation in this study: i) Known Hypersensitivity to FRAGMIN (Dalteparin), or its constituents including benzyl alcohol or to other low molecular weight heparins and/or heparins or pork products ii) Known history of confirmed or suspected immunologically-mediated heparininduced thrombocytopenia (delayed-onset severe thrombocytopenia), and/or in patients with a known history of a positive in vitro platelet-aggregation test in the presence of FRAGMIN (Dalteparin) is positive iii) Known septic endocarditis iv) Uncontrollable active bleeding v) Known major blood clotting disorders vi) Known acute gastroduodenal ulcer (with active bleeding) vii) Severe uncontrolled hypertension (i.e. BP>210 despite medications) viii) Known diabetic or hemorrhagic retinopathy ix) Anticipated to be unable to receive SCD on at least one lower extremity due to nature of injuries for duration of intervention period x) Presence of another confounding factor that can adequately explain the poor GCS at time of presentation (e.g. drug toxicity, seizure).
- •xi) Known presence of irreversible coagulopathies.
- •xii) Known Pregnancy xiii) Participants extremely low weight (<45 kg), or extremely high weight (>120kg) xiv) Not expected to survive more than 48 hours from admission If it is determined after enrolment that if an enrolled patient had an exclusion criterion at the time of randomization which was not previously identified, the study drug will be discontinued.
- •In these situations, the steering committee will review each case to determine whether the patient should also be excluded from the intention to treat analysis.
结局指标
主要结局
1. Symptomatic, objectively-confirmed PE.
时间窗: 30 days, 180 days
2. Symptomatic, objectively-confirmed, proximal leg DVT. In this case,
时间窗: 30 days, 180 days
symptomatic would suggest that the patient has developed leg swelling or
时间窗: 30 days, 180 days
signs of venous stasis that can be directly attributed to a DVT during the first
时间窗: 30 days, 180 days
7 study days, and this DVT would need to be objectively confirmed (for
时间窗: 30 days, 180 days
example using Doppler ultrasound).
时间窗: 30 days, 180 days
3. Asymptomatic proximal leg DVT on Doppler ultrasound on Day 8-1 or +2 days
时间窗: 30 days, 180 days
(at Day 7, 8, 9 or 10) after Initiation of study drug. In this case, the DVT is
时间窗: 30 days, 180 days
detected during our routine screening on Day 8-1 or +2 days (at Day 7, 8, 9 or
时间窗: 30 days, 180 days
10), and need not be associated with symptoms
时间窗: 30 days, 180 days
次要结局
- Secondary Outcomes(1. Objectively confirmed new or progressing ICB on radiology assessed by)