ClinicalTrials.gg
RecruitingNCT06870812REACHUpdated Aug 14, 2026

Rapid Evacuation and Access of Cerebral Hemorrhage Trial

An interventional study of Surgical management and Medical Management in Stroke Hemorrhagic, sponsored by Emory University. Recruiting at 24 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by Emory University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started May 2025; still recruiting 1 year 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

Read the detailed description

The REACH trial, which stands for Rapid Evacuation and Access of Cerebral Hemorrhage Trial, is a medical research study aimed at finding better ways to treat people who have had a specific type of stroke called an intracerebral hemorrhage. This type of stroke happens when a blood vessel bursts and causes bleeding in the brain.

Traditionally, treating this kind of stroke has been challenging, and the best approach is not always clear. Recently, trials have shown that minimally invasive surgery to remove the clot caused by bleeding improves outcomes and decreases death when the blood is located closer to the surface of the skull. The REACH trial is testing the same minimally invasive surgery to remove the blood clot caused by the bleeding in a deeper part of the brain. The goal is to see if this approach can improve recovery and outcomes for patients compared to standard medical care.

In simple terms, the REACH trial is trying to find out if using a less invasive surgical technique can help people recover better and faster after a bleeding stroke in the deeper part of the brain.

02

Conditions studied

  • Stroke Hemorrhagic

Keywords

  • Intracerebral hemorrhage
  • minimally invasive surgery
  • Blood clot
03

In context

Hemorrhagic Stroke

233 studies on the registry are indexed under Hemorrhagic Stroke; 93 are open to participants now.

This study's planned enrollment of 600 is above the median of 58 across 156 interventional studies indexed under Hemorrhagic Stroke.

Browse Hemorrhagic Stroke studies →

Lead sponsor

Emory University is the lead sponsor of 1,405 studies on the registry; 225 are open to participants now.

Of its 237 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18-70 years
  • 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)
  • ICH volume between 20 - 80 mL as calculated by an approved and standardized volumetric measurement
  • 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.
  • Glasgow Coma Score (GCS) 5 - 14
  • Historical Modified Rankin Score 0 or 1

Exclusion criteria

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 (less than 1 year) ICH, as diagnosed with radiographic imaging
  • NIH Stroke Scale (NIHSS) less than or equal to 5
  • Bilateral fixed dilated pupils
  • Extensor motor posturing
  • Intraventricular extension of the hemorrhage is visually estimated to involve greater than 50% of either of the lateral ventricles
  • Primary thalamic ICH or basal ganglia hemorrhage with involvement > 25% of thalamus
  • Infratentorial intraparenchymal hemorrhage including midbrain, pontine, or cerebellar
  • Use of anticoagulants that cannot be rapidly reversed (i.e., criteria is met if investigators are confident that coagulopathy is not present after targeted correction)
  • Evidence of active bleeding involving a retroperitoneal, gastrointestinal, genitourinary, or respiratory tract site
  • Uncorrected coagulopathy or known clotting disorder
  • Known count less than 75,000 or known (INR) greater than 1.4 after correction
  • Patients requiring long-term anti-coagulation that needs to be initiated less than or equal to 5 days from initial ICH
  • End-stage renal disease
  • Patients with a mechanical heart valve
  • End-stage liver disease
  • History of drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
  • Positive urine or serum pregnancy test in female subjects without documented history of surgical sterilization or
  • Known of less than 6 months before ICH
  • No reasonable expectation of recovery, do-not-resuscitate (DNR), or comfort measures only before randomization
  • Participation in a concurrent interventional medical investigation or clinical trial. Patients in non-interventional/observational studies are eligible
  • Inability or unwillingness of the subject or legal guardian/representative to give written
  • Homelessness or inability to meet follow-up requirements
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    Surgical management (MIPS) plus medical management

    Participants randomized to surgical management will follow the Medical Manual of the Clinical Standardization Guidelines (CSG) before and after surgery.

    Procedure: Surgical management · Other: Medical Management

  • Active comparator
    medical management.

    Participants randomized to the medical management alone will be treated according to the Clinical Standardization Guidelines (CSG).

    Other: Medical Management

Interventions

  • ProcedureSurgical management

    Following randomization into the surgical arm, a competency-trained neurosurgeon will perform the MIPS for clot evacuation with strict adherence to the Surgical Manual of the CSG. Image interpretation, patient position, anesthetic plan, stereotactic navigation registration, exoscopic positioning, access, optics, resection, and hemostasis are detailed in the Surgical Manual of the CSG. The OR arrival time should occur \<24 hours from the last known normal (LKN) with a goal of arrival in less than 8 hours from the last known normal.

    Also known as: Early minimally invasive parafascicular surgery (MIPS)

  • OtherMedical Management

    Following randomization into the medical arm patients will be treated following the Medical Manual of the CSG. The Medical Manual has been adapted by the REACH Executive Committee (REC) from the current American Heart Association (AHA) and American Stroke Association (ASA) Guidelines for the Management of Spontaneous Intracerebral Hemorrhage. Whenever clinically feasible, the CSG should be followed as it represents a template for the care of these subjects. The Medical Manual details specialty level of care, including intensive care placement, blood pressure control, hemostasis and coagulopathy, anemia, deep venous thrombosis and pulmonary embolism prophylaxis/treatment, glucose management, temperature management, seizure prophylaxis, intracranial pressure monitoring and management, intraventricular hemorrhage (IVH)/obstructive hydrocephalus management, cerebral edema, decompressive hemicraniectomy, nutritional support, respiratory support, and comfort care.

    Also known as: Standard of Care (SOC)

06

What researchers measure

Primary outcomes

  1. Score on the modified Rankin Scale (mRS) at

    The mRS is a seven-level ordinal scale that ranges from 0 (no symptoms) to 6 (death).

    Time frame: 180 days after randomization

Secondary outcomes

  1. Hospital mortality

    Mortality rate during hospitalization will be calculated.

    Time frame: Up to 14 days (average hospital stay)

  2. All-cause mortality at discharge from the initial hospitalization

    All-cause mortality rate will be calculated.

    Time frame: 30 days after randomization

  3. Change in hematoma volume

    The change in hematoma volume from the initial to the follow-up neuroimaging for surgical management versus medical management.

    Time frame: Baseline and up to 36 hours post-randomization

  4. Post-operative rebleeding associated with neurologic deterioration

    Post-operative rebleeding associated with neurologic deterioration (defined as a growth in hematoma volume between the initial CT and follow-up neuroimaging and an increase of 4 or more points on the NIH stroke scale or a decrease of up to 2 points on the GCS that was not explained by planned medical interventions \[e.g., sedatives, analgesics, and procedures\]). \*This outcome applies to the surgery group only.

    Time frame: Up to 36 hours post-randomization

  5. Serious adverse events

    All adverse events will be recorded f after randomization until the final follow-up visit.

    Time frame: 180-days post-randomization

  6. Number of participants who required a decompressive hemicraniectomy

    Number of participants who required a decompressive hemicraniectomy in each group during initial hospitalization.

    Time frame: Up to 14 days (average stay in the hospital)

  7. Intensive care unit (ICU) length-of-stay (LoS)

    Total number of days spent in ICU

    Time frame: Up to 7 days (average stay in ICU)

  8. Duration of mechanical ventilation between groups

    Duration that patients required mechanical ventilation

    Time frame: Up to 7 days (average ICU stay)

07

Study locations

17 of 24 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — The research team will share de-identified data upon reasonable request and approval by the Executive Committee no earlier than one year after the primary manuscript is published.

Supporting information: Study protocol, Statistical analysis plan, Analytic code

Time frame: Data will become available one year after the publication of the primary manuscript.

Access criteria: One year after the publication, academic institutions or industry researchers may submit requests to contribute to tertiary, meta, and other exploratory analyses and publications to the publications committee, provided they include a methodologically sound proposal. Proposals should be sent to REACHTRIAL@emory.edu. Data Transfer Agreements may be required.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2025 (actual). Primary completion is estimated for Mar 2030, 58 months after the start.

Of 75 non-industry interventional studies with no phase under Hemorrhagic Stroke, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 57. This study's planned 58 months is above that.

Counting every sponsor, half of 89 studies reached it within 36 months; a quarter within 14 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 6, 2025
First posted
Mar 11, 2025
StartActual
May 27, 2025
Primary completionEst.
Mar 2030
CompletionEst.
Mar 2030
Last update
Aug 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06870812
Lead sponsor
Emory University
Collaborators
The Marcus Foundation
Responsible party
Alex Hall (Assistant Professor, Emory University) — Principal investigator
First posted
Mar 11, 2025
Start date
May 27, 2025
Primary completion
Mar 2030 (estimated)
Completion
Mar 2030 (estimated)
Last update
Aug 14, 2026

Study contacts

Alex Hall, DHSc
Contact
alex.hall@emory.edu
404-778-1585
Alex Hall, DHSc
principal investigator · Emory University
Gustavo Pradilla, MD
principal investigator · Emory University
Jonathan Ratcliff, MD
principal investigator · Emory University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion