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Safety and efficacy of surgical treatment in critical primary pontine hemorrhage evacuation (STIPE): a multicentric, randomized, controlled, open-label, phase 2 trial

Safety and efficacy of surgical treatment in critical primary pontine hemorrhage evacuation (STIPE): a multicentric, randomized, controlled, open-label, phase 2 trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039679
Enrollment
Unknown
Registered
2020-11-05
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary pontine hemorrhage

Interventions

Experimental group:suigical treatment
control:mendical treatment

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Diagnostic criteria for PPH: A history of hypertension, the main hematoma in pontine (whether or not extend to the midbrain or medulla oblongata or ventricle, with or without obstructive hydrocephalus); 2. GCS 5ml (measured with the ABC/2, where A is the greatest hemorrhage diameter on CT, B is the diameter 90 degrees to A, and C is the number of CT slices multiplied by the slice thickness, intraventricular hemorrhage not included in HV); 3. The family members agreeing to surgery and signing ICF; 4. The time from onset to admission less than 24 hours; 5. The age between 18 and 75 years old.

Exclusion criteria

Exclusion criteria: 1. PPH caused by specific causes such as brain aneurysm or cavernous hemangioma or trauma; 2. A history of coagulation dysfunction or anticoagulant drugs; 3. Multiple ICH; 4. PPH with severe brain injury; 5. Terminal brain hernia (presented bilateral pupil dilation and fixation, no spontaneous breathing, blood pressure not be maintained); 6. GCS >= 8 and HV < 5ml; 7. Patients with liver and/or kidney failure or complicated with systemic malignancy, and life expectancy less than 1 year 8. A history of mental disorders or neurological disorders; 9. A previous history of ICH; 10. Pregnant patients.

Design outcomes

Primary

MeasureTime frame
mortality rate and intracranial infection rate in 30 days;Rebleeding rate within 3 days after operation;

Secondary

MeasureTime frame
Modified Rankin scoring Scale;NIH Stroke Scale;Glasgow Outcome Scale;Extended Glasgow Outcome Scale;Quality of Life (ED-5Q);Quality of Life Self-rating scale;

Countries

China

Contacts

Public ContactChao You

Department of Neurosurgery, West China Hospital,Sichuan University

youchao@vip.126.com+86 18980601505

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026