2024-511679-14-00尚未招募2 期
Improving outcome in subarachnoid hemorrhage with nadroparin
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 30-days’ mortality
研究概览
简要总结
Our primary objective is to evaluate whether aSAH patients treated with therapeutic dose LMWH have a lower 30-day mortality rate compared to aSAH patients treated with prophylactic dose LMWH.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •SAH confirmed by CT or lumbar puncture with the causative aneurysm confirmed by CT-A and/or DSA
- •Coiling of the causative aneurysm within 72 hours of initial SAH
- •Informed consent before the first scheduled administration of the study medicine
- •Adult age (≥18 years)
排除标准
- •Stent-assisted coiling
- •Use of anticoagulant or dual antiplatelet medication post-coiling for other reasons
- •Incomplete aneurysm occlusion/partial coiling
- •Intraparenchymal hemorrhage
- •Contra-indications for LMWH: o Previous history of history of heparin-induced thrombocytopenia o (Suspicion of) active arterial or venous bleeding o Previous history of hemorrhagic diathesis due to coagulation disorders (with the ex-ception of disseminated intravascular coagulation) o Severe hypertension: uncontrolled hypertension with a MAP > 135mmHg o Previous history of hypertensive or diabetic retinopathy o Previous history of active infectious endocarditis o Severe renal impairment (creatinine clearance <30 mL / min)
- •No proficiency of Dutch or English language
- •Proven and active COVID-19 infection
结局指标
主要结局
30-days’ mortality
30-days’ mortality
次要结局
- Mortality at six months
- Delayed cerebral ischemia
- Venous thrombo-embolic complications
- Intra- and extracranial hemorrhagic complications
- Hemorrhage after external CSF drainage
- Rate of other SAH-related complications with subdividing into types of complications
- Hydrocephalus
- Discharge location
- Quality of life
- Cognitive functioning
- Clinical outcome (modified Rankin Score)
- Rate of (micro)infarctions number and volume at MR imaging at six months
研究者
D. Verbaan
Scientific
Amsterdam UMC Stichting
研究点 (1)
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