Recruiting

Observational Study

Sponsor:

Emory University

Code:

NCT07651631

Conditions

Intracerebral Hemorrhage

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The goal of this observational study is to quantify the real-world effect of minimally invasive surgery (MIS) in patients with acute spontaneous supratentorial intracerebral hemorrhage.

Conditions

Intracerebral Hemorrhage

Study ID

NCT07651631

Start date

Aug 12, 2026

Status verified date

Aug, 2026

Completion date

Jun, 2033

Anticipated

Primary completion date

Jun, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Head CT demonstrating an acute, spontaneous, intracerebral hemorrhage
  • Hemorrhage volume ≥ 20 mLs
  • Minimally invasive surgical intervention performed within 7 days of hemorrhage

Exclusion Criteria:

  • Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, moyamoya disease, venous sinus thrombosis, mass or tumor, hemorrhagic conversion of an ischemic infarct, recurrence of a recent ICH (<1 year), as diagnosed with radiographic imaging
  • Infratentorial intraparenchymal hemorrhage, including midbrain, pontine, or cerebellum
  • Initial hospital arrival ≥ 24 hours after the onset of stroke symptoms
  • Last known normal is unknown
  • Historical Modified Rankin Score > 4
  • Known life-expectancy of less than 1 year prior to ICH
  • DNR or comfort measures only
  • Known pregnancy in female subjects
  • Inability or unwillingness of subject or legal guardian/representative to give written informed consent within 7 days of initial hospital arrival
  • Inability to meet follow up requiremen

Study Design

Enrollment

2500 participants

Anticipated

Interventions and Outcome Measures

Arms

Minimally Invasive Surgical Groups

  • Surgical A: Endport evacuation (i.e., MIPS via BrainPath or similar device)
  • Surgical B: Endoscopic evacuation
  • Surgical C: Catheter-based evacuation
  • Surgical D: Other minimally invasive surgical techniques involving clot evacuation

Control Group

No minimally invasive surgical hematoma evacuation performed; n=300 total, capped across 20 sites; may include patients undergoing decompressive hemicraniectomy or other standard medical/surgical approaches):

  • Basal Ganglia Controls (>50% IVH or ICH volume ≥80 mL; n=100)
  • Lobar Controls (ICH volume ≥80 mL; n=100)
  • Primary Thalamic Controls (n=100)
  • ENRICH Trial Controls (ABG and lobar locations; n=150)
  • REACH Trial Controls (ABG location; n=maximum 300)

Primary outcome measure

  • Modified Rankin Scale (mRS) at 180 Days [ Time Frame: Day 180 from baseline (±14 days) ]
  • 30-Day Mortality [ Time Frame: Day 30 (±7 days) ]

Central Contacts and Locations

Central contacts

Alex Hall, DHSc

404-778-1585alex.hall@emory.edu

Locations

Grady Memorial Hospital

Recruiting

Atlanta, Georgia, United States, 30303

Principal Investigator:

Alex Hall, DHSc, MS

More Information

Sponsor

Emory University

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

  • Intracerebral Hemorrhage
  • ICH is the basal ganglia
  • modified Rankin Scale
  • Arteriovenous Malformation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-08-26.