CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 733 enrolled
Drug / intervention
Endoscopic Evacuation +2 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02811614
NCT02811614N/ACompleted
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Minimally-invasive Surgery Versus Craniotomy in Patients With Supratentorial Hypertensive Intracerebral Hemorrhage: A Multi-center Randomized Controlled Trial

Chinese PLA General Hospital·interventional·Posted Jun 23, 2016·Updated Feb 22, 2023

In Brief

A clinical study evaluating Endoscopic Evacuation, Stereotactic Aspiration, and 1 other intervention for Intracranial Hemorrhage, Hypertensive. Completed, enrolled 733 participants across 1 site.

Detailed Summary

The effectiveness of craniotomy in the treatment of intracerebral hemorrhage remains controversial. Two main types of minimally invasive surgery, endoscopic evacuation and stereotactic aspiration, have been attempted for hematoma removal and show some advantages. However, prospective and controlled studies are still lacking. This is a multi-center randomized controlled trial designed to determine whether minimally invasive hematoma evacuation with endoscopic or stereotactic aspiration will improve the outcome in patients with hypertensive intracerebral hemorrhage compared with small-boneflap craniotomy. Patients will be randomly assigned to endoscopy group, stereotactic aspiration group or small-boneflap craniotomy group in a 1:1:1 ratio.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIntracranial Hemorrhage, Hypertensive
CountriesChina
CollaboratorsJingzhou Central Hospital, Wuhan No.1 Hospital, Yichang Central People's Hospital, Second Hospital of Jilin University, The First Affiliated Hospital of Nanchang University, Second Affiliated Hospital of Nanchang University, Tang-Du Hospital, First Affiliated Hospital, Sun Yat-Sen University, Jiangmen Central Hospital, Jilin Province People's Hospital, Siping Central People's Hospital, Minzu Hospital of Guangxi Zhuang Autonomous Region, Taihe Hospital

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 23, 2016
Enrollment StartJul 1, 2016
Primary CompletionJun 30, 2022
Study CompletionJul 31, 2022
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 10.0 years ago

Interventions

Endoscopic Evacuationprocedure

Endoscopic surgery for treatment of supratentorial hypertensive intracerebral hemorrhage.

Stereotactic Aspirationprocedure

Using image guidance to aspirate hematoma.

Craniotomyprocedure

Craniotomy with a big bone flap to evacuate intracerebral hematoma.