Minimal Invasive Surgical Intracerebral Hemorrhage Removal — HEALME  

Intracranial Hemorrhages Clinical Trial

Official title: Hyperacute mEchAnicaL Endoscopic Minimally Invasive Surgical (MIS) Intracranial Hemorrhage Evacuation

Status Not yet recruiting

Clinical Trial Summary

This is a feasibility study trial to determine whether hyperacute (≤8 hour) mechanical Minimal Invasive Surgical (MIS) management is feasible and secondarily improves outcome in patients with spontaneous supratentorial intracranial hemorrhage (ICH).

Patients meeting the inclusion and exclusion criteria, will be enrolled and randomized to either minimally invasive hematoma evacuation (MIS) or best medical management alone (MM). Subjects will be randomly assigned by a central web-based system in a 3:1 manner to treatment with MIS or MM. Data for each subject will be collected at the time of enrollment and treatment, and at subsequent follow-up visits.

Clinical Trial Description

The proposed study seeks to determine whether hyperacute (≤8 hour) mechanical MIS management is feasible and improves outcome in patients with spontaneous supratentorial intracranial hemorrhage (ICH).

• Screening The subject will be evaluated as any non-traumatic spontaneous intra-parenchymal hemorrhage patient including medical history screened, available clinical/neurological exams (focused exam, NIHSS, GCS, historical mRS), ECG, laboratory work, and imaging information per institutional standard of care. A CTA (or MRA) will be performed, as standard of care.

• Randomization After all inclusion and exclusion criteria are confirmed and written informed consent obtained, randomization will occur. Subjects will be randomized to best MM or MIS.

• Treatment Procedure (if randomized to MIS) Minimally Invasive Surgical evacuation.

• Treatment Procedure (if randomized to MM) There is no intervention for the control group beyond the current standard of care provided at The Ottawa Hospital. Subjects randomized to the MM group will receive best MM for ICH according to Canadian Best Practice Recommendations for ICH care. Outcomes assessments will be in accordance to table 2.

• Post procedure, D1, D2 and D5 or discharging A post-procedural computed tomographic scan will be obtained within 24 hours (± 6 hours) for MIS group. Clinical assessment such as NIHSS, mRS, NCCT head, computed tomographic Angiogram, adverse event assessment will be conducted as SOC for MIS group (Table 2 in protocol).

A CT will be obtained in MM subjects 24 hours (± 6 hours) after randomization. Adverse event assessment will be conducted for MM subjects 4-6 hours after randomization. Neurological and functional exams will be conducted in D1 and D2 after randomization (Table 2 in protocol).

Follow-up visits (D30, D90): (Both MIS and MM groups) Follow-ups will be combined with phone and onsite visit. D30 will be conducted over the phone, and D90 will be onsite visit. The follow-ups will involve clinical assessment such as NIHSS, Glasgow Coma Scale, EuroQol- 5 Dimension (EQ-5D), mRS, Barthel, Glasgow Outcome Scale (GOSE), adverse event assessment, concomitant. medications. ;

Related Conditions & MeSH terms

• Hemorrhage
• Intracranial Hemorrhages

• NCT number: NCT05138341
• Study type: Interventional
• Source: The Ottawa Hospital
• Contact: Richard Aviv, MD
• Phone: 6137985555
• Email: raviv@toh.ca
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2024
• Completion date: December 31, 2025