Evaluating the safety of surgery for severe primary pontine hemorrhage

Safety of Surgical Treatment In Severe Primary Pontine Hemorrhage Evacuation (STIPE): a Multicentric, Randomized, Controlled, Open-label Trial

This study is testing different types of surgery to see if they can safely help patients with severe primary pontine hemorrhage.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: West China Hospital (other)
• Locations: 20 sites (Hefei, Anhui and 19 other locations)
• Trial ID: NCT04647162 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety of surgical interventions for patients suffering from severe primary pontine hemorrhage (PPH), a critical condition with high mortality rates. Conducted across 20 tertiary hospitals in China, the trial employs a randomized controlled design to compare different surgical techniques, including craniotomy, stereotactic puncture, and neuroendoscopy. Patients with a Glasgow Coma Score between 5 and 7 and specific hematoma characteristics will be included, while those with certain exclusion criteria will be omitted. The study aims to provide evidence on the effectiveness of surgical treatment in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of severe primary pontine hemorrhage and a Glasgow Coma Score between 5 and 7.

Not a fit: Patients with Glasgow Coma Scores of 8 or higher, or those with specific structural brain lesions or other serious conditions, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved survival rates and better prognoses for patients with severe primary pontine hemorrhage.

How similar studies have performed: Previous studies have indicated that surgical interventions can be effective for similar conditions, but this specific approach for severe primary pontine hemorrhage is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Clinical diagnosis of PPH: patients have acute hemorrhage mainly in pons with a definite history of hypertension.
2. GCS 5\~7 and HV≥5ml on admission (the HV in intraventricular system being excluded).
3. Family members consenting to randomize and signing informed consent form (ICF).
4. Time from onset to admission less than 24 hours.
5. Age:18 years or older.

Exclusion Criteria:

1. Structural lesions such as brainstem cavernous malformation, arteriovenous malformation, aneurysm, tumor apoplexy.
2. GCS≥8 and HV\<5ml.
3. Time from onset to admission over 24 hours.
4. Patients with platelet count \< 100,000, International Normalized Ratio (INR)\> 1.4, or an elevated prothrombin time (PT) and activated partial thromboplastin time (APTT).
5. Multiple ICH.
6. Accompanying hydrocephalus that requires surgical management
7. Irreversible brainstem failure (bilateral fixed, dilated pupils and extensor motor posturing, GCS≤4).
8. A previous history of ICH.
9. Any serious concurrent illness that would interfere with the safety assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease.
10. Pregnant patients.
11. Patients' family members refuse HE.
12. Any other condition that the investigator believes would present a significant hazard to the subject if the investigational therapy were initiated.
13. Participating in another simultaneous trial of ICH treatment.

Where this trial is running

Hefei, Anhui and 19 other locations

• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (RECRUITING)
• The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (RECRUITING)
• Gaozhou Hospital of Traditional Chinese Medicine Affiliated to Guangzhou University of Chinese Medicine — Gaozhou, Guangdong, China (RECRUITING)
• Guangdong Sanjiu Brain Hospital — Guangzhou, Guangdong, China (RECRUITING)
• University of Chinese Academy of Sciences Shenzhen Hospital — Shenzhen, Guangdong, China (RECRUITING)
• The Second Affiliated Hospital of South China University of Technology — Shenzhen, Guangdong, China (RECRUITING)
• Zhuhai People's Hospital — Zhuhai, Guangdong, China (RECRUITING)
• The First Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (RECRUITING)
• The Second Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (RECRUITING)
• General Hospital of the Eastern Theater — Nanjing, Jiangsu, China (RECRUITING)
• Shanxi Bethune hospital — Taiyuan, Shanxi, China (RECRUITING)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (RECRUITING)
• Mianyang Central Hospital — Mianyang, Sichuan, China (RECRUITING)
• Affiliated Hospital of North Sichuan Medical College — Nanchong, Sichuan, China (RECRUITING)
• The Third Hospital of the People's Liberation Army — Baoji, China (RECRUITING)
• The seventh medical center of the Army General Hospital — Beijing, China (RECRUITING)
• Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, China (RECRUITING)
• Huashan Hospital of Fudan University — Shanghai, China (RECRUITING)
• Shanghai No.10 hospital — Shanghai, China (RECRUITING)
• Xuhui Hospital of Zhongshan Hospital affiliated to Fudan — Shanghai, China (RECRUITING)

Study contacts

• Principal investigator: Chao You, MD — West China Hospital
• Study coordinator: Chao You, MD

Conditions: Cerebrovascular Disorders, Pontine Hemorrhage, Primary, Surgery