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

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ClinicalTrials.gov Identifier: NCT04647162
Recruitment Status : Recruiting
First Posted : November 30, 2020
Last Update Posted : July 26, 2022
Sponsor:
Information provided by (Responsible Party):
Chao You, MD, West China Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Cerebrovascular Disorders Pontine Hemorrhage Primary Surgery Procedure: hematoma evacuation by craniotomy Procedure: hematoma evacuation by stereotactic puncture Procedure: hematoma evacuation by neuroendoscopy Other: life support Not Applicable

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A sample size of 60 would be required to demonstrate a significant level of 5% (two-sided) with 80% power. Considering the 6% missing rate during follow-up, the total sample size was 64 cases with 16 and 48 cases in MT and HE group, respectively.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety of Surgical Treatment In Severe Primary Pontine Hemorrhage Evacuation (STIPE): a Multicentric, Randomized, Controlled, Open-label Trial
Actual Study Start Date : January 1, 2022
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: medical group
Patients receive only medical treatment including active life support, nutritional support, homeostasis maintenance of the internal environment, and other symptomatic treatment.
 Other: life support
The treatments in medical group includes life support, nutrition support, and rehabilitation therapy。
Experimental: surgical group
Patients receive intervention such as the evacuation of hematoma under craniotomy or by stereotactic puncture or neuroendoscopy.
 Procedure: hematoma evacuation by craniotomy
The intervention method of hematoma evacuation is under craniotomy.

Procedure: hematoma evacuation by stereotactic puncture
The intervention method of hematoma evacuation is under stereotactic puncture.

Procedure: hematoma evacuation by neuroendoscopy
The intervention method of hematoma evacuation is under neuroendoscopy.


Outcome Measures
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Primary Outcome Measures :
  1. Safety Outcome Number 1: Rate of Mortality [ Time Frame: 30 days from randomization ]
    Percentage of participants who died during the first 30 days after randomization.

  2. Safety Outcome Number 2: Rate of Cerebritis, Meningitis, Bacterial Ventriculitis [ Time Frame: 30 days from randomization ]
    Percentage of participants who had a bacterial brain infection (cerebritis, meningitis, ventriculitis) within 30 days of randomization.

  3. Safety Outcome Number 3: Rate of Symptomatic Rebleeding [ Time Frame: 72 hours post surgery ]
    The difference in the rate of symptomatic rebleeding 72 hours post surgery.


Secondary Outcome Measures :
  1. the rate of hematoma clearance 3 days after surgery [ Time Frame: 3 days after surgery ]
    the rate of hematoma clearance 3 days after surgery

  2. all-cause mortality at 365 days [ Time Frame: 365 days after surgery ]
    all-cause mortality at 365 days

  3. neurological functional status of 30 days, 90 days, 180 days, and 365 days measured by Modified Rankin Scale (mRS), GCS and GOS. [ Time Frame: 30 days, 90 days, 180 days, and 365 days after surgery ]
    neurological functional status of 30 days, 90 days, 180 days, and 365 days measured by Modified Rankin Scale (mRS), GCS and GOS.

  4. The Extended Glasgow Outcome Scale (EGOS) at 180 days and 365 days [ Time Frame: 180 days and 365 days after surgery ]
    The Extended Glasgow Outcome Scale (EGOS) at 180 days and 365 days

  5. The 5-level EuroQol five dimensions questionnaire (EQ-5D) version (EQ-5D-5L) at 180 days and 365 days [ Time Frame: 180 days and 365 days after surgery ]
    The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The former descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The latter is numbered from 0 to 100. 100 means the best health you can imagine. 0 means the worst health you can imagine.

  6. the National Institutes of Health Stroke Scale (NIHSS) at 180 days and 365 days [ Time Frame: 180 days and 365 days after surgery ]
    the National Institutes of Health Stroke Scale (NIHSS) at 180 days and 365 days


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   based on the identity card
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04647162


Contacts
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Contact: Chao You, MD +86 028-85422488 youchao@vip.126.com
Contact: Qiang He, MD +86 15099189463 heqiang629@126.com

Locations
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Sponsors and Collaborators
West China Hospital
Investigators
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Principal Investigator: Chao You, MD West China Hospital
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Chao You, MD, former director of the department of neurosurgery, West China Hospital, West China Hospital
ClinicalTrials.gov Identifier: NCT04647162    
Other Study ID Numbers: STIPE
First Posted: November 30, 2020    Key Record Dates
Last Update Posted: July 26, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Hemorrhage
Pathologic Processes
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases