A Clinical Trial About the Safety of Surgical Treatment in Severe Primary Pontine Hemorrhage

Last updated: December 6, 2023
Sponsor: West China Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hemorrhage

Surgery

Neurologic Disorders

Treatment

hematoma evacuation by neuroendoscopy

hematoma evacuation by stereotactic puncture

life support

Clinical Study ID

NCT04647162
STIPE
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Clinical diagnosis of PPH: patients have acute hemorrhage mainly in pons with adefinite 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

Exclusion Criteria:

  1. Structural lesions such as brainstem cavernous malformation, arteriovenousmalformation, 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, oran 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 motorposturing, GCS≤4).
  8. A previous history of ICH.
  9. Any serious concurrent illness that would interfere with the safety assessmentsincluding 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 hazardto the subject if the investigational therapy were initiated.
  13. Participating in another simultaneous trial of ICH treatment.

Study Design

Total Participants: 64
Treatment Group(s): 4
Primary Treatment: hematoma evacuation by neuroendoscopy
Phase:
Study Start date:
January 01, 2022
Estimated Completion Date:
November 30, 2024

Study Description

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.

Connect with a study center

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui
    China

    Active - Recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian
    China

    Active - Recruiting

  • Gaozhou Hospital of Traditional Chinese Medicine Affiliated to Guangzhou University of Chinese Medicine

    Gaozhou, Guangdong
    China

    Active - Recruiting

  • Guangdong Sanjiu Brain Hospital

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • The Second Affiliated Hospital of South China University of Technology

    Shenzhen, Guangdong
    China

    Active - Recruiting

  • University of Chinese Academy of Sciences Shenzhen Hospital

    Shenzhen, Guangdong 518000
    China

    Active - Recruiting

  • Zhuhai People's Hospital

    Zhuhai, Guangdong
    China

    Active - Recruiting

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan
    China

    Active - Recruiting

  • General Hospital of the Eastern Theater

    Nanjing, Jiangsu
    China

    Active - Recruiting

  • The Second Affiliated College of Suzhou University

    Suzhou, Jiangsu
    China

    Site Not Available

  • Shanxi Bethune hospital

    Taiyuan, Shanxi
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan
    China

    Active - Recruiting

  • Mianyang Central Hospital

    Mianyang, Sichuan
    China

    Active - Recruiting

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan
    China

    Active - Recruiting

  • The Third Hospital of the People's Liberation Army

    Baoji,
    China

    Active - Recruiting

  • The seventh medical center of the Army General Hospital

    Beijing,
    China

    Active - Recruiting

  • Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou,
    China

    Active - Recruiting

  • Huashan Hospital of Fudan University

    Shanghai,
    China

    Active - Recruiting

  • Shanghai No.10 hospital

    Shanghai,
    China

    Active - Recruiting

  • Xuhui Hospital of Zhongshan Hospital affiliated to Fudan

    Shanghai,
    China

    Active - Recruiting

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