Cerebrovascular Disorders, Pontine Hemorrhage, Primary, Surgery
Conditions
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.
Interventions
PROCEDUREhematoma evacuation by craniotomy
The intervention method of hematoma evacuation is under craniotomy.
PROCEDUREhematoma evacuation by stereotactic puncture
The intervention method of hematoma evacuation is under stereotactic puncture.
PROCEDUREhematoma evacuation by neuroendoscopy
The intervention method of hematoma evacuation is under neuroendoscopy.
OTHERlife support
The treatments in medical group includes life support, nutrition support, and rehabilitation therapy。
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Outcome Number 1: Rate of Mortality | 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 | 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 | 72 hours post surgery | The difference in the rate of symptomatic rebleeding 72 hours post surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| the rate of hematoma clearance 3 days after surgery | 3 days after surgery | the rate of hematoma clearance 3 days after surgery |
| 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 |
| 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. |
| all-cause mortality at 365 days | 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. | 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. |
Countries
China
Contacts
Primary ContactChao You, MD
Backup ContactQiang He, MD
Outcome results
None listed