RECRUITING

Rapid Evacuation and Access of Cerebral Hemorrhage Trial

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Conditions

Stroke HemorrhagicIntracerebral hemorrhageminimally invasive surgeryBlood clot

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main purpose of this study is to compare patients with a deep bleed in the brain undergoing surgery to patients receiving routine medical care. The standard treatment involves admission to the Intensive Care Unit (ICU) with close monitoring and blood pressure control. It also includes other medical (non-surgical) treatments to prevent more bleeding or another stroke. Sometimes, doctors will recommend surgery to remove the blood if medical treatment alone is not successful. There is evidence that doing minimally invasive surgery early-using a small opening in the skull to remove blood-may help some patients. Researchers aim to understand whether this surgery is better than current medical treatment, which may include surgeries to relieve pressure on the brain in some cases. This study, called REACH, is comparing usual medical care to early minimally invasive surgery so doctors can know which is better for patients.

Official Title

Rapid Evacuation and Access of Cerebral Hemorrhage Trial

Quick Facts

Study Start:2025-05-27
Study Completion:2030-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06870812

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-70 years
  2. * Pre-randomization head CT demonstrating an acute, spontaneous, anterior basal ganglia primary intracerebral hemorrhage (ICH) (the anterior basal ganglia include the caudate, putamen, and pallidum to the capsula externa and excludes the thalamus)
  3. * ICH volume between 20 - 80 mL as calculated by an approved and standardized volumetric measurement
  4. * Study intervention can reasonably be initiated within 24 hours after the onset of stroke symptoms. If the onset is unclear, then the onset will be considered the time that the subject was last known to be well.
  5. * Glasgow Coma Score (GCS) 5 - 14
  6. * Historical Modified Rankin Score 0 or 1
  1. * 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 (less than 1 year) ICH, as diagnosed with radiographic imaging
  2. * NIH Stroke Scale (NIHSS) less than or equal to 5
  3. * Bilateral fixed dilated pupils
  4. * Extensor motor posturing
  5. * Intraventricular extension of the hemorrhage is visually estimated to involve greater than 50% of either of the lateral ventricles
  6. * Primary thalamic ICH or basal ganglia hemorrhage with involvement \> 25% of thalamus
  7. * Infratentorial intraparenchymal hemorrhage including midbrain, pontine, or cerebellar
  8. * Use of anticoagulants that cannot be rapidly reversed (i.e., criteria is met if investigators are confident that clinically significant coagulopathy is not present after targeted correction)
  9. * Evidence of active bleeding involving a retroperitoneal, gastrointestinal, genitourinary, or respiratory tract site
  10. * Uncorrected coagulopathy or known clotting disorder
  11. * Known platelet count less than 75,000 or known international normalized ratio (INR) greater than 1.4 after correction
  12. * Patients requiring long-term anti-coagulation that needs to be initiated less than or equal to 5 days from initial ICH
  13. * End-stage renal disease
  14. * Patients with a mechanical heart valve
  15. * End-stage liver disease
  16. * History of drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
  17. * Positive urine or serum pregnancy test in female subjects without documented history of surgical sterilization or post-menopausal
  18. * Known life expectancy of less than 6 months before ICH
  19. * No reasonable expectation of recovery, do-not-resuscitate (DNR), or comfort measures only before randomization
  20. * Participation in a concurrent interventional medical investigation or clinical trial. Patients in non-interventional/observational studies are eligible
  21. * Inability or unwillingness of the subject or legal guardian/representative to give written informed consent
  22. * Homelessness or inability to meet follow-up requirements

Contacts and Locations

Study Contact

Alex Hall, DHSc
CONTACT
404-778-1585
alex.hall@emory.edu

Principal Investigator

Alex Hall, DHSc
PRINCIPAL_INVESTIGATOR
Emory University
Gustavo Pradilla, MD
PRINCIPAL_INVESTIGATOR
Emory University
Jonathan Ratcliff, MD
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Grady Memorial Hospital
Atlanta, Georgia, 30303
United States
Emory Hospital Midtown
Atlanta, Georgia, 30308
United States
Emory University Hospital (EUH)
Atlanta, Georgia, 30322
United States

Collaborators and Investigators

Sponsor: Emory University

  • Alex Hall, DHSc, PRINCIPAL_INVESTIGATOR, Emory University
  • Gustavo Pradilla, MD, PRINCIPAL_INVESTIGATOR, Emory University
  • Jonathan Ratcliff, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-27
Study Completion Date2030-03

Study Record Updates

Study Start Date2025-05-27
Study Completion Date2030-03

Terms related to this study

Keywords Provided by Researchers

  • Intracerebral hemorrhage
  • minimally invasive surgery
  • Blood clot

Additional Relevant MeSH Terms

  • Stroke Hemorrhagic