Safety of Surgical Treatment In Severe Primary Pontine Hemorrhage Evacuation (STIPE): a Multicentric, Randomized, Controlled, Open-label Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 20
- 主要终点
- Safety Outcome Number 3: Rate of Symptomatic Rebleeding
研究概览
简要总结
Primary pontine hemorrhage (PPH) is not common but is the most catastrophic subtype of intracerebral hemorrhage, with acute mortality between 30% and 60%. For severe PPH, defined as Glasgow Coma score (GCS) <8 and hematoma volume≥5ml, the mortality rate is as high as 80-100%. Guidelines from the American Heart Association and European Stroke Organization do not make definite specifications. More than a century after Finkelnburg first explored the brainstem for hematoma, however, plenty of researches have shown surgery can save lives and improve the prognosis for selective patients and can be an effective and safe treatment. This study is proposed to validate the safety of surgical treatment in severe primary pontine hemorrhage.
详细描述
The study is being conducted from Jan 2022 to Nov 2024 in 20 neurosurgical units. This STIPE trial is an investigator-initiated, parallel (3:1 to surgical HE or MT), multi-centre, randomized controlled open-label trial following the Consolidated Standards of Reporting Trials (CONSORT) guidelines and will be conducted from Jan 2022 to Nov 2024 in 20 Tertiary hospitals in China. The flow chart of the clinical trial is presented in Figure 1. Neurosurgeons involved in the study are senior investigators with good clinical experience in sPPH management. Moreover, all investigators are well trained centrally according to the requirements.
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 (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
- •Clinical diagnosis of PPH: patients have acute hemorrhage mainly in pons with a definite history of hypertension.
- •GCS 5~7 and HV≥5ml on admission (the HV in intraventricular system being excluded).
- •Family members consenting to randomize and signing informed consent form (ICF).
- •Time from onset to admission less than 24 hours.
- •Age:18 years or older.
排除标准
- •Structural lesions such as brainstem cavernous malformation, arteriovenous malformation, aneurysm, tumor apoplexy.
- •GCS≥8 and HV<5ml.
- •Time from onset to admission over 24 hours.
- •Patients with platelet count < 100,000, International Normalized Ratio (INR)> 1.4, or an elevated prothrombin time (PT) and activated partial thromboplastin time (APTT).
- •Multiple ICH.
- •Accompanying hydrocephalus that requires surgical management
- •Irreversible brainstem failure (bilateral fixed, dilated pupils and extensor motor posturing, GCS≤4).
- •A previous history of ICH.
- •Any serious concurrent illness that would interfere with the safety assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease.
- •Pregnant patients.
- •Patients' family members refuse HE.
- •Any other condition that the investigator believes would present a significant hazard to the subject if the investigational therapy were initiated.
- •Participating in another simultaneous trial of ICH treatment.
研究组 & 干预措施
medical group
Patients receive only medical treatment including active life support, nutritional support, homeostasis maintenance of the internal environment, and other symptomatic treatment.
干预措施: life support (Other)
surgical group
Patients receive intervention such as the evacuation of hematoma under craniotomy or by stereotactic puncture or neuroendoscopy.
干预措施: hematoma evacuation by craniotomy (Procedure)
surgical group
Patients receive intervention such as the evacuation of hematoma under craniotomy or by stereotactic puncture or neuroendoscopy.
干预措施: hematoma evacuation by stereotactic puncture (Procedure)
surgical group
Patients receive intervention such as the evacuation of hematoma under craniotomy or by stereotactic puncture or neuroendoscopy.
干预措施: hematoma evacuation by neuroendoscopy (Procedure)
结局指标
主要结局
Safety Outcome Number 3: Rate of Symptomatic Rebleeding
时间窗: 72 hours post surgery
The difference in the rate of symptomatic rebleeding 72 hours post surgery.
Safety Outcome Number 1: Rate of Mortality
时间窗: 30 days from randomization
Percentage of participants who died during the first 30 days after randomization.
Safety Outcome Number 2: Rate of Cerebritis, Meningitis, Bacterial Ventriculitis
时间窗: 30 days from randomization
Percentage of participants who had a bacterial brain infection (cerebritis, meningitis, ventriculitis) within 30 days of randomization.
次要结局
- neurological functional status of 30 days, 90 days, 180 days, and 365 days measured by Modified Rankin Scale (mRS), GCS and GOS.(30 days, 90 days, 180 days, and 365 days after surgery)
- The Extended Glasgow Outcome Scale (EGOS) at 180 days and 365 days(180 days and 365 days after surgery)
- the rate of hematoma clearance 3 days after surgery(3 days after surgery)
- all-cause mortality at 365 days(365 days after surgery)
- The 5-level EuroQol five dimensions questionnaire (EQ-5D) version (EQ-5D-5L) at 180 days and 365 days(180 days and 365 days after surgery)
- the National Institutes of Health Stroke Scale (NIHSS) at 180 days and 365 days(180 days and 365 days after surgery)
研究者
Chao You, MD
former director of the department of neurosurgery, West China Hospital
West China Hospital