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NCT05138341: HEALME

Minimal Invasive Surgical Intracerebral Hemorrhage Removal

Status unknown NA Last updated 3 November 2023
What this trial tests

NA trial testing Minimally invasive surgical (MIS) intracranial hemorrhage Evacuation in Intracranial Hemorrhages in 16 participants. Status unknown.

Timeline
1 November 2024
Primary endpoint
31 December 2025
31 December 2025

Quick facts

Lead sponsorThe Ottawa Hospital
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment16
Start date1 November 2024
Primary completion31 December 2025
Estimated completion31 December 2025

Drugs / interventions tested

Conditions studied

Sponsor

The Ottawa Hospital

Who can join

18 and older, any sex, with Intracranial Hemorrhages. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Surgery for spontaneous supratentorial intracerebral haemorrhage.
    Wilting FN, Sondag L, Schreuder FH, Dammers R, et al · · 2025 · cited 5× · PMID 40673401 · DOI 10.1002/14651858.cd015387.pub2
  2. The potential for minimally invasive intracerebral hemorrhage evacuation in routine healthcare: applicability of the ENRICH trial criteria to an unselected cohort.
    Apostolaki-Hansson T, Hillal A, Göransson N, Hansen BM, et al · · 2024 · PMID 41542253 · DOI 10.3389/fstro.2024.1403812

Verify or expand the search:

Other recruiting trials for Intracranial Hemorrhages

Currently open trials in the same condition.

Other The Ottawa Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing