CTRI/2023/08/056550尚未招募3 期
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
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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
研究者
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