An interventional study of Endoscopic Evacuation and Stereotactic Aspiration in Intracranial Hemorrhage, Hypertensive, sponsored by Chinese PLA General Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-02-22.
Sponsored by Chinese PLA General Hospital · Not applicable, Interventional, and Treatment
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.
Hypertensive intracerebral hemorrhage (HICH) is the most common hemorrhagic stroke. The morbidity and mortality exceed 60% and only 12% patients could live independently. The choice of surgical or conservative treatment for patients with HICH is controversial.
Some minimally invasive neurosurgeries have been applied to hematoma evacuation and may improve prognosis to some extent. In endoscopic evacuation, a small burr hole is created and hematoma is removed through suction and irrigation under neuroendoscope. Endoscopic surgical evacuation promise to maximize hematoma evacuation while minimizing damage to normal tissue. Stereotactic aspiration uses image guidance to place a catheter into the main body of the hematoma and aspirate blood. It is estimated that 720 patients (240 patients in each treatment group) would provide 90% power and a type I error probability of .05 to detect an effect size of 13% with a 10% dropout rate taken into consideration. Patients will receive endoscopic evacuation, stereotactic aspiration or craniotomy according to the results of randomization. Patients will be followed up at 7 days, 30 days and 6 months.
Outcomes of different groups of patients will be collected and compared. The study is designed to find a best surgical method for hypertensive intracerebral hemorrhage.
476 studies on the registry are indexed under Cerebral Hemorrhage; 181 are open to participants now.
This study's enrollment of 733 is above the median of 100 across 287 interventional studies indexed under Cerebral Hemorrhage.
Browse Cerebral Hemorrhage studies →Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Endoscopic hematoma evacuation with the help of a self-developed working channel.
Procedure: Endoscopic Evacuation
Place a catheter into the main body of the hematoma and aspirate blood.
Procedure: Stereotactic Aspiration
Craniotomy with a big bone flap to for hematoma evacuation.
Procedure: Craniotomy
Endoscopic surgery for treatment of supratentorial hypertensive intracerebral hemorrhage.
Also known as: neuroendoscopic surgery
Using image guidance to aspirate hematoma.
Also known as: Hematoma Stereotactic Aspiration
Craniotomy with a big bone flap to evacuate intracerebral hematoma.
Also known as: Craniotomy evacuation of hematoma
Modified Rankin Scale
The degree of disability or dependence in the daily activities. The scale runs from 0-6, running from perfect health without symptoms to death.
Time frame: 6 months
Hematoma Clearance Rate
A ratio assessing extent of hematoma evacuation, ranging from 0 to 100%.
Time frame: 24 hours and 3 days
Operation Time
The time from skin incision to the end of surgery.
Time frame: 24 hours
Intraoperative Blood Loss
Volume of blood lost during operation.
Time frame: 24 hours
Postoperative Glasgow Coma Scale
A neurological scale to record the conscious state of patients at 1 week after surgery.
Time frame: 7 days
Rebleeding Rate
The percentage of patients that suffer from rebleeding after surgery. Rebleeding usually occurs within 3 days after surgery.
Time frame: 3 days
Days of ICU Stay
The time an ICH patient has to stay in intensive care unit after surgery.
Time frame: 14 days
Mortality
The percentage of patients that die within a month after the onset of hypertensive intracerebral hemorrhage.
Time frame: 30 days
Intracranial Infection Rate
Percentage of patients that get intracranial infection. The infection should be confirmed by cerebrospinal fluid tests.
Time frame: 7 days
Barthel Index
An ordinal scale used to measure performance of patients in activities of daily living. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital.
Time frame: 6 months
Hospitalization expenses
Total expenses during neurosurgery hospitalization
Time frame: 6 months
Plan to share: Yes
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Chinese PLA General Hospital