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

Sponsor
West China Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04647162
Collaborator
(none)
64
Enrollment
20
Locations
2
Arms
34
Anticipated Duration (Months)
3.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: hematoma evacuation by craniotomy
  • Procedure: hematoma evacuation by stereotactic puncture
  • Procedure: hematoma evacuation by neuroendoscopy
  • Other: life support
 N/A

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

Study Type:
Interventional
Anticipated 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.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 :
Jan 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

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

Primary Outcome Measures

  1. Safety Outcome Number 1: Rate of Mortality [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 [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 [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 [3 days after surgery]

    the rate of hematoma clearance 3 days after surgery

  2. all-cause mortality at 365 days [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. [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 [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 [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 [180 days and 365 days after surgery]

    the National Institutes of Health Stroke Scale (NIHSS) at 180 days and 365 days

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Anhui Medical University Hefei Anhui China
2 The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian China
3 Gaozhou Hospital of Traditional Chinese Medicine Affiliated to Guangzhou University of Chinese Medicine Gaozhou Guangdong China
4 Guangdong Sanjiu Brain Hospital Guangzhou Guangdong China
5 University of Chinese Academy of Sciences Shenzhen Hospital Shenzhen Guangdong China 518000
6 The Second Affiliated Hospital of South China University of Technology Shenzhen Guangdong China
7 Zhuhai People's Hospital Zhuhai Guangdong China
8 The First Affiliated Hospital of Harbin Medical University Harbin Heilongjiang China
9 The Second Affiliated Hospital of Zhengzhou University Zhengzhou Henan China
10 General Hospital of the Eastern Theater Nanjing Jiangsu China
11 Shanxi Bethune hospital Taiyuan Shanxi China
12 West China Hospital of Sichuan University Chengdu Sichuan China
13 Mianyang Central Hospital Mianyang Sichuan China
14 Affiliated Hospital of North Sichuan Medical College Nanchong Sichuan China
15 The Third Hospital of the People's Liberation Army Baoji China
16 The seventh medical center of the Army General Hospital Beijing China
17 Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou China
18 Huashan Hospital of Fudan University Shanghai China
19 Shanghai No.10 hospital Shanghai China
20 Xuhui Hospital of Zhongshan Hospital affiliated to Fudan Shanghai China

Sponsors and Collaborators

  • West China Hospital

Investigators

  • Principal Investigator: Chao You, MD, West China Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

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:
Nov 30, 2020
Last Update Posted:
Jul 26, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cerebrovascular Disorders
Hemorrhage

Study Results

No Results Posted as of Jul 26, 2022