Rapid Evacuation and Access of Cerebral Hemorrhage Registry
ConditionIntracerebral Hemorrhage
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEmory University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Head CT demonstrating an acute, spontaneous, intracerebral hemorrhage
Hemorrhage volume ≥ 20 mLs
Minimally invasive surgical intervention performed within 7 days of hemorrhage
Disqualifiers
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
Trial population
Subjects with acute, spontaneous supratentorial intracerebral hemorrhage.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
2,500 Participants
are grouped into 2 trial groupsGroup A: Minimally Invasive Surgical Groups
Group B: Control Group
Trial outcomes
Primary outcomes
1
Modified Rankin Scale (mRS) at 180 Days
Functional outcome will be assessed using the modified Rankin Scale (mRS), a 7-level ordinal scale ranging from 0 (no symptoms) to 6 (death). The primary endpoint evaluates real-world functional recovery following minimally invasive surgery (MIS) for acute supratentorial ICH. Structured interview performed in person or via telephone by trained study personnel; audio-recorded and centrally adjudicated.
Time frame
Day 180 from baseline (±14 days)2
30-Day Mortality
All-cause mortality within 30 days of the initial hemorrhage.
Time frame
Day 30 (±7 days)Other outcomes
1
modified Rankin Scale (mRS) at Additional Time Points
The endpoint evaluates real-world functional recovery following minimally invasive surgery (MIS) for acute supratentorial ICH. Collected over phone or in-person via structured interview.
Time frame
Day 7, 30, 90, 180, 3652
Post-Operative Infection or CSF Leak
Incidence of surgical site infection or cerebrospinal fluid leak.
Time frame
Baseline through Day 3653
Quality of Life (EQ-5D-5L)
The EQ-5D-5L assesses health status across five dimensions: * Mobility * Self-care * Usual activities * Pain/discomfort * Anxiety/depression Each dimension has five levels (no problems, slight problems, moderate problems, severe problems, extreme problems), allowing patients to describe their health using a five-digit health state (e.g., 11223). Patients also complete a Visual Analogue Scale (VAS) rating their overall health from 0 (worst imaginable) to 100 (best imaginable)
Time frame
Day 7, 30, 90, 180, 3654
Follow-Up Neuroimaging (24-Hour)
Assessment of hematoma evacuation effectiveness and residual volume.
Time frame
Within 24 hours post-procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
The Marcus Foundation
Collaborator
Source ClinicalTrials.gov