A Clinical Trial About the Safety of Surgical Treatment in Severe Primary Pontine Hemorrhage (STIPE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04647162|
Recruitment Status : Recruiting
First Posted : November 30, 2020
Last Update Posted : July 26, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|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)|
|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|
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.
- 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.
- 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.
- 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.
- the rate of hematoma clearance 3 days after surgery [ Time Frame: 3 days after surgery ]the rate of hematoma clearance 3 days after surgery
- all-cause mortality at 365 days [ Time Frame: 365 days after surgery ]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. [ 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.
- 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
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|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|
- 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.
- 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.
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
|Contact: Chao You, MD||+86 email@example.com|
|Contact: Qiang He, MD||+86 firstname.lastname@example.org|
|Principal Investigator:||Chao You, MD||West China Hospital|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Chao You, MD, former director of the department of neurosurgery, West China Hospital, West China Hospital|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Central Nervous System Diseases
Nervous System Diseases