Back to resultsA Clinical Trial About the Safety of Surgical Treatment in Severe Primary Pontine Hemorrhage (STIPE)
Primary Purpose
Cerebrovascular Disorders, Pontine Hemorrhage, Primary
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
hematoma evacuation by craniotomy
hematoma evacuation by stereotactic puncture
hematoma evacuation by neuroendoscopy
life support
Sponsored by
About this trial
This is an interventional treatment trial for Cerebrovascular Disorders
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- The First Affiliated Hospital of Anhui Medical UniversityRecruiting
- The First Affiliated Hospital of Fujian Medical UniversityRecruiting
- Gaozhou Hospital of Traditional Chinese Medicine Affiliated to Guangzhou University of Chinese MedicineRecruiting
- Guangdong Sanjiu Brain HospitalRecruiting
- University of Chinese Academy of Sciences Shenzhen HospitalRecruiting
- The Second Affiliated Hospital of South China University of TechnologyRecruiting
- Zhuhai People's HospitalRecruiting
- The First Affiliated Hospital of Harbin Medical UniversityRecruiting
- The Second Affiliated Hospital of Zhengzhou UniversityRecruiting
- General Hospital of the Eastern TheaterRecruiting
- Shanxi Bethune hospitalRecruiting
- West China Hospital of Sichuan UniversityRecruiting
- Mianyang Central HospitalRecruiting
- Affiliated Hospital of North Sichuan Medical CollegeRecruiting
- The Third Hospital of the People's Liberation ArmyRecruiting
- The seventh medical center of the Army General HospitalRecruiting
- Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting
- Huashan Hospital of Fudan UniversityRecruiting
- Shanghai No.10 hospitalRecruiting
- Xuhui Hospital of Zhongshan Hospital affiliated to FudanRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
medical group
surgical group
Arm Description
Patients receive only medical treatment including active life support, nutritional support, homeostasis maintenance of the internal environment, and other symptomatic treatment.
Patients receive intervention such as the evacuation of hematoma under craniotomy or by stereotactic puncture or neuroendoscopy.
Outcomes
Primary Outcome Measures
Safety Outcome Number 1: Rate of Mortality
Percentage of participants who died during the first 30 days after randomization.
Safety Outcome Number 2: Rate of Cerebritis, Meningitis, Bacterial Ventriculitis
Percentage of participants who had a bacterial brain infection (cerebritis, meningitis, ventriculitis) within 30 days of randomization.
Safety Outcome Number 3: Rate of Symptomatic Rebleeding
The difference in the rate of symptomatic rebleeding 72 hours post surgery.
Secondary Outcome Measures
the rate of hematoma clearance 3 days after surgery
the rate of hematoma clearance 3 days after surgery
all-cause mortality at 365 days
all-cause mortality at 365 days
neurological functional status of 30 days, 90 days, 180 days, and 365 days measured by Modified Rankin Scale (mRS), GCS and GOS.
neurological functional status of 30 days, 90 days, 180 days, and 365 days measured by Modified Rankin Scale (mRS), GCS and GOS.
The Extended Glasgow Outcome Scale (EGOS) at 180 days and 365 days
The Extended Glasgow Outcome Scale (EGOS) at 180 days and 365 days
The 5-level EuroQol five dimensions questionnaire (EQ-5D) version (EQ-5D-5L) at 180 days and 365 days
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.
the National Institutes of Health Stroke Scale (NIHSS) at 180 days and 365 days
the National Institutes of Health Stroke Scale (NIHSS) at 180 days and 365 days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04647162
Brief Title
A Clinical Trial About the Safety of Surgical Treatment in Severe Primary Pontine Hemorrhage
Acronym
STIPE
Official Title
Safety of Surgical Treatment In Severe Primary Pontine Hemorrhage Evacuation (STIPE): a Multicentric, Randomized, Controlled, Open-label Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Disorders, Pontine Hemorrhage, Primary, Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
medical group
Arm Type
Active Comparator
Arm Description
Patients receive only medical treatment including active life support, nutritional support, homeostasis maintenance of the internal environment, and other symptomatic treatment.
Arm Title
surgical group
Arm Type
Experimental
Arm Description
Patients receive intervention such as the evacuation of hematoma under craniotomy or by stereotactic puncture or neuroendoscopy.
Intervention Type
Procedure
Intervention Name(s)
hematoma evacuation by craniotomy
Intervention Description
The intervention method of hematoma evacuation is under craniotomy.
Intervention Type
Procedure
Intervention Name(s)
hematoma evacuation by stereotactic puncture
Intervention Description
The intervention method of hematoma evacuation is under stereotactic puncture.
Intervention Type
Procedure
Intervention Name(s)
hematoma evacuation by neuroendoscopy
Intervention Description
The intervention method of hematoma evacuation is under neuroendoscopy.
Intervention Type
Other
Intervention Name(s)
life support
Intervention Description
The treatments in medical group includes life support, nutrition support, and rehabilitation therapy。
Primary Outcome Measure Information:
Title
Safety Outcome Number 1: Rate of Mortality
Description
Percentage of participants who died during the first 30 days after randomization.
Time Frame
30 days from randomization
Title
Safety Outcome Number 2: Rate of Cerebritis, Meningitis, Bacterial Ventriculitis
Description
Percentage of participants who had a bacterial brain infection (cerebritis, meningitis, ventriculitis) within 30 days of randomization.
Time Frame
30 days from randomization
Title
Safety Outcome Number 3: Rate of Symptomatic Rebleeding
Description
The difference in the rate of symptomatic rebleeding 72 hours post surgery.
Time Frame
72 hours post surgery
Secondary Outcome Measure Information:
Title
the rate of hematoma clearance 3 days after surgery
Description
the rate of hematoma clearance 3 days after surgery
Time Frame
3 days after surgery
Title
all-cause mortality at 365 days
Description
all-cause mortality at 365 days
Time Frame
365 days after surgery
Title
neurological functional status of 30 days, 90 days, 180 days, and 365 days measured by Modified Rankin Scale (mRS), GCS and GOS.
Description
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
Title
The Extended Glasgow Outcome Scale (EGOS) at 180 days and 365 days
Description
The Extended Glasgow Outcome Scale (EGOS) at 180 days and 365 days
Time Frame
180 days and 365 days after surgery
Title
The 5-level EuroQol five dimensions questionnaire (EQ-5D) version (EQ-5D-5L) at 180 days and 365 days
Description
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.
Time Frame
180 days and 365 days after surgery
Title
the National Institutes of Health Stroke Scale (NIHSS) at 180 days and 365 days
Description
the National Institutes of Health Stroke Scale (NIHSS) at 180 days and 365 days
Time Frame
180 days and 365 days after surgery
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
based on the identity card
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chao You, MD
Phone
+86 028-85422488
Email
youchao@vip.126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qiang He, MD
Phone
+86 15099189463
Email
heqiang629@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chao You, MD
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongwei Cheng, MD
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dezhi Kang, MD
Facility Name
Gaozhou Hospital of Traditional Chinese Medicine Affiliated to Guangzhou University of Chinese Medicine
City
Gaozhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinhua Yang, MD
Facility Name
Guangdong Sanjiu Brain Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linsen Mu, MD
Facility Name
University of Chinese Academy of Sciences Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuezheng Fan, MD
Phone
18126081550
Email
835646710@qq.com
Facility Name
The Second Affiliated Hospital of South China University of Technology
City
Shenzhen
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiangang Liu, MD
Facility Name
Zhuhai People's Hospital
City
Zhuhai
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gang Chen, MD
Facility Name
The First Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongsheng Liang, MD
Facility Name
The Second Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhan Liu, MD
Facility Name
General Hospital of the Eastern Theater
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chiyuan Ma, MD
Facility Name
Shanxi Bethune hospital
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinming Ding, MD
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chao You, MD
Facility Name
Mianyang Central Hospital
City
Mianyang
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zongping Li, MD
Facility Name
Affiliated Hospital of North Sichuan Medical College
City
Nanchong
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoping Tang, MD
Facility Name
The Third Hospital of the People's Liberation Army
City
Baoji
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rongjun Zhang
Facility Name
The seventh medical center of the Army General Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongtian Zhang, MD
Facility Name
Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fengqiang Liu
Facility Name
Huashan Hospital of Fudan University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Yu, MD
Facility Name
Shanghai No.10 hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Gao, MD
Facility Name
Xuhui Hospital of Zhongshan Hospital affiliated to Fudan
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shujie Sun, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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A Clinical Trial About the Safety of Surgical Treatment in Severe Primary Pontine Hemorrhage
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