Efficacy and Safety of Factor VIIa (Eptacog Alfa) on Rebleeding After Surgery for Spontaneous Supratentorial Intracerebral Hemorrhage. A Randomized, Controlled, Open-Label, Investigator-Blinded Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Evaluate the efficacy of Factor VIIa (Eptacog alfa) in preventing or reducing rebleeding after surgery for spontaneous supratentorial ICH
研究概览
简要总结
Although the role of surgical treatment is still controversial, surgical evacuation of intracerebral hematoma is a frequent practice. Rebleeding is a frequent complication in patients submitted to hematoma evacuation. It has been reported that smaller postoperative volume of hematoma is associated with a better outcome. The investigators hypothesize that the administration of Factor VIIa (Eptacog alfa) immediately after surgical evacuation of the hematoma can reduce postoperative rebleeding.
Aims of the Study:
This study will investigate:
- The efficacy of Eptacog alfa in preventing or reducing rebleeding after surgery for spontaneous supratentorial ICH; and
- The safety of product administration
详细描述
The primary endpoint is the evaluation of efficacy of Factor VIIa (Eptacog alfa, NovoSeven, Novo Nordisk) on rebleeding after surgery for primary supratentorial ICH. All patients included in the study will perform a CT scan within 3 hours before surgery, then immediately after surgery, and 18-30 hours after surgery. The hematoma volume will be evaluated by a multi-slice CT scan. All CT scan images will be sent to the Coordinating Center where the hematoma volume will be evaluated by a dedicated software by the same investigator who will be unaware of the treatment (investigator- blinded study).
SAFETY EVALUATION:
Seventeen episodes of thrombotic spontaneous adverse events have been reported after administration of 480,000 standard doses of Eptacog alfa in hemophilic patients. These episodes include myocardial infarction, acute cerebrovascular thrombosis, disseminated intravascular coagulation (DIC), deep venous thrombosis (DVT) and pulmonary embolism.
Before and after hematoma removal will be evaluated ECG, myocardiac enzymes, coagulation profile, CT scan (looking for ischemic events) and venous echodoppler ultrasound of lower extremities.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18-75 years inclusive
- •Intraparenchymal primary supratentorial intracerebral hemorrhage requiring surgical evacuation
- •Any Glasgow Coma Score (GCS) score
- •Surgery expected to be performed within 24 hours from symptoms onset
排除标准
- •Age below 18
- •Intraparenchymal hematoma secondary to rupture of cerebral aneurysm or bleeding of arteriovenous (A-V) malformation or cerebral tumors
- •Contemporary involvement in another study
- •Pregnancy
- •Myocardial infarction in the six months preceding enrolment
- •Coronary or carotid stents positioned in the six months preceding enrolment
- •Solid organ transplant patients (e.g., heart, lung, liver, kidney)
- •Pregnancy
- •Myocardial infarction in the six months preceding enrolment
- •Coronary and carotid stents positioned in the six months preceding enrolment
- •Solid organ transplant patients (e.g., heart, lung, liver, kidney)
研究组 & 干预措施
1
Patients treated with recombinant FVIIa
干预措施: rFactor VIIa (Eptacog alfa, NovoNordisk) (Drug)
1
Patients treated with recombinant FVIIa
干预措施: rFVIIa (Drug)
2
Patients with spontaneous supratentorial ICH included in this arm will be treated with placebo
干预措施: Sodiun chloride 0.9% (Other)
结局指标
主要结局
Evaluate the efficacy of Factor VIIa (Eptacog alfa) in preventing or reducing rebleeding after surgery for spontaneous supratentorial ICH
时间窗: 4 years
次要结局
- Safety of product administration(4 years)