Endoscopic Surgery versus Conventional Craniotomy for the Treatment of Spontaneous Intracerebral Hemorrhage

Phase 4

Completed

• Conditions: Spontaneous supratentorial intracerebral hemorrhage; intracerebral hemorrhage; endoscopic surgery; outcome

• Registration Number: TCTR20200116002
• Lead Sponsor: none

Brief Summary

For patients with supratentorial ICH who were surgically indicated, ES was more beneficial in functional outcomes than CC. In addition, ICH removal with ES was performed in a shorter operative time and less blood loss with comparable complications. These findings confirmed the safety and efficacy of clot removal with minimizing brain injury during endoscopic removal of ICH.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-16
• Study Completion: 2022-06-22
• Results First Posted: 2023-06-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. newly diagnosed spontaneous intracerebral hemorrhage in supratentorial area
2. hematoma volume > 30 ml
3. Glasgow coma score 5-14 or NIHSS > 6
4. able to start treatment within 24 hours after the onset
5. SBP < 200 mmHg or MAP < 130 mHG more than 6 hours before treatment
6. Modified Rankin Scale 0-1 before the onset

Exclusion Criteria

1. intracerenral hemorrhage associated with ruptured cerebral aneurysms, vascular malformations, Moyamoya disease, venous sinus thrombosis, tumor, trauma, hemorrhagic transforamtion of cerebral infarction or recurrent hemorrhage within 1 year
2. Bilateral fixed dilated pupils or extensor motor posturing
3. Presence of intraventricular hemorrhage >50% in lateral ventricle or obtructive hydrocephalus
4. infratentorial hemorrhage
5. coagulopathy
6. active bleeding in gastrointestinal, retroperitoneal, or respiratory tract
7. Platelet count < 100,000 or internaltional normalized ratio > 1.3
8. End stage renal or liver disease or other disease contraindicated for surgery
9. pregnancy
10. Unidentified subjects or lack of care-givers

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eurologic disability Posttreatment 6 month Modified Rankin Scale

Secondary Outcome Measures

Name	Time	Method
eurologic disability Posttreatment 1 and 3 month Modified Rankin Scale,Mortality Posttreatment Mortality rate,Hematoma removal volume Posttreatment Clot reduction volume,Complications Posttreatment Complication event rate,Rebleeding Posttreatment rebleeding rate,Hospital stay from admission to dischage length of hospital stay (day)