A Phase II Trial on the Safety and Efficacy of C1 Inhibitor for the Acute Management of Subarachnoid Hemorrhage
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Number of participants with delayed cerebral ischemia (DCI)
研究概览
简要总结
Aneurysmal subarachnoid hemorrhage (SAH) can lead to devastating outcomes for patients, like cognitive decline. This is caused by early brain injury (EBI) followed by delayed cerebral ischemia (DCI). Neuroinflammation, triggered by the complement system, has been investigated to be a key mediator in the pathophysiology of EBI and DCI. Inhibition of the complement system is therefore considered to be a potentially important new treatment for SAH.
This trial aims to study the safety and efficacy of C1-inhibitor Cinryze, an approved inhibitor of the complement system, compared to placebo in patients with SAH. By temporarily blocking the complement system we hypothesize limitation of delayed cerebral ischemia and a more favourable clinical outcome for SAH patients due to a decrease in the inflammatory response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Confirmed diagnosis of aneurysmal subarachnoid hemorrhage on CT-scan;
- •Age ≥ 18 years on admission;
- •WFNS grade 1-5.
排除标准
- •Subarachnoid hemorrhage deemed most likely of 'peri mesencephalic' origin after consideration of history, clinical examination and radiological findings (including angiographic imaging); (not originated from an aneurysm and patients have by definition a favourable clinical outcome)
- •Subarachnoid hemorrhage deemed most likely of post-traumatic origin after consideration of history, clinical examination and radiological findings (including angiographic imaging); (does not occur spontaneous)
- •Participation in another clinical therapeutic study;
- •Patients with definite infaust prognosis on arrival and/or expected death within 24 hours of admission
- •Patients with a known hereditary complement deficiency (including hereditary angioedema);
- •Patients with a history of sensibility to blood products or C1-inhibitor;
- •Patients with a history of thrombosis (when known at time of inclusion);
- •Pregnant woman
研究组 & 干预措施
C1-esterase inhibitor (Cinryze)
One group receiving study medication (C1-esterase inhibitor Cinryze)
干预措施: C1 Esterase Inhibitor Injection [Cinryze] (Drug)
Placebo
One group receiving placebo medication
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with delayed cerebral ischemia (DCI)
时间窗: To be determined between day 4 and day 14 of admission
Defined as either a new focal neurological impairment, or a decrease of at least 2 points on the Glasgow Coma Scale. This should last for at least 1 hour, is not apparent immediately after aneurysm occlusion, and cannot be attributed to other causes by means of clinical assessment, CT or MRI scanning of the brain, and appropriate laboratory studies.
Number of participants with complications during hospitalization.
时间窗: Up to 1 year after admission
Complication rate during hospitalization
次要结局
- Number of ICU days(Up to 1 year)
- Number of participants with cerebral infarction on brain CT(at 14 days after admission)
- Number of participants dying(Up to 1 year after admission)
- Neurological condition measured by Glasgow Coma Scale(During the first 14 days)
- Complement activity markers measured in serum and CSF(Before IV administration of C1-INH or placebo, and after 48 hours and 96 hours after IV administration)
- Inflammatory markers measured in serum and CSF(Before IV administration of C1-INH or placebo, and after 48 hours and 96 hours after IV administration)
- Number of days in the hospital(Up to 1 year)
- Number of ventilator days(Up to 1 year)
- Clinical outcome(At 6 months)
研究者
Wouter Moojen
Principal Investigator
Haaglanden Medical Centre