Minimal Invasive Surgical Intracerebral Hemorrhage Removal

Launched by THE OTTAWA HOSPITAL · Nov 17, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to treat patients who have bleeding in the brain, known as intracerebral hemorrhage (ICH), that happens suddenly and is diagnosed using a CT scan. The goal of the study is to see if a minimally invasive surgical method, which involves removing the blood clot within 8 hours of the bleeding starting, can help improve patient outcomes compared to the standard medical treatment alone. Participants will be randomly assigned to either receive the minimally invasive surgery or just the best medical care available.

To be eligible for this trial, participants need to be adults over 18 years old and have a certain type of brain bleeding that is not caused by trauma or other medical conditions. They should also have a specific range of symptoms and blood pressure levels. If someone joins the study, their health information will be collected when they start treatment and at follow-up visits to see how they are doing. This study is not yet recruiting participants, but it aims to determine if this new surgical approach can be a safe and effective option for those with spontaneous brain bleeding.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. CT diagnosed acute spontaneous primary supratentorial ICH.
• • 2. Age \>18 years
• • 3. Baseline ICH volume 20-80 ml, estimated using the standard "A\*B\*C/2"calculation on the baseline CT.
• • 4. NIHSS≥6 and Glasgow Coma Scale score 8-12, on initial screening.
• • 5. Premorbid Modified Rankin score (MRS) ≤1
• • 6. Systolic blood pressure140-180 millimeters of mercury (mmHg) with 160mmHg target according to practice guidelines
• • 7. Randomize and first evacuation attempt ≤8 hours onset using the "last seen normal" principle.
• • 8. Consent obtained from patient or their Substitute Decision Maker prior to enrolment.
• Exclusion Criteria:
• • 1. Infratentorial ICH (Brainstem or cerebellum).
• • 2. ICH secondary to known or suspected trauma, aneurysm, vascular malformation, hemorrhagic conversion of ischemic stroke, venous sinus thrombosis, thrombolytic treatment, tumour, or infection; or an in-hospital ICH or ICH because of any in-hospital procedure or illness.
• • 3. Baseline brain imaging shows evidence of acute or subacute ischemic stroke (chronic infarcts are not an exclusion).
• • 4. Platelets \<100000, International Normalized ratio (INR)\>1.3 or clotting disorder. Coumadin reversal permitted if not required during hospitalization
• • 5. Serious comorbidities including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease or mechanical valve
• • 6. Impaired brainstem function (bilateral fixed dilated pupils, extensor posturing).
• • 7. Patient considered unstable in opinion of investigator.
• • 8. Positive pregnancy test