Surgical vs Medical Management for Intracerebral Hemorrhage

(REACH Trial)

Recruiting at 6 trial locations

Overseen By Alex Hall, DHSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Must not be taking: Anticoagulants

Disqualifiers: Ruptured aneurysm, AVM, Moyamoya, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 14 days

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to treat a deep brain bleed by comparing surgery with standard medical care. Researchers are examining whether minimally invasive surgery, which uses a small opening to remove the blood, proves more effective than the usual medical approach. They aim to determine if surgery helps prevent further damage or complications. Ideal participants are those who have experienced a sudden, deep brain bleed and can begin treatment within 24 hours of symptom onset. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on anticoagulants (blood thinners) that cannot be quickly reversed, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that minimally invasive surgery for brain bleeds can be safe for patients. One study found no major safety issues when performed early. Specifically, patients who underwent surgery within 6 to 8 hours of symptom onset demonstrated better outcomes and safety. Another study suggested that this surgery might reduce the risk of death in patients with larger blood clots.

While surgery appears promising, some studies have mixed results on whether it consistently leads to better recovery compared to medical care alone. However, early surgery seems beneficial in many cases, especially when performed soon after symptoms begin. Overall, evidence supports that many patients tolerate this surgical approach well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about examining surgical management for intracerebral hemorrhage because it offers a direct approach to removing blood clots from the brain, potentially reducing pressure and damage more quickly than medical management alone. Unlike traditional medical management that relies on medication to manage symptoms and prevent complications, surgical intervention can directly address the source of the problem. This combined approach with medical management aims to improve patient outcomes by integrating the strengths of both surgical and medical strategies.

What evidence suggests that this trial's treatments could be effective for intracerebral hemorrhage?

Research has shown that less invasive surgery for brain bleeding can help some patients. In this trial, participants in the surgical management arm will receive this type of surgery. One study demonstrated that it significantly reduced the death rate at three months compared to medication alone. Another study found that surgery could improve both survival and recovery at six months. These findings suggest that making a small opening in the skull to remove the blood might aid recovery better than medical treatment alone, which is the focus of the medical management arm in this trial. However, past research has not shown the same benefits for traditional open surgery. ^{1 3 4 6 7}

Who Is on the Research Team?

Alex Hall, DHSc

Principal Investigator

Emory University

Gustavo Pradilla, MD

Principal Investigator

Emory University

Jonathan Ratcliff, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for individuals who have experienced a deep hemorrhagic stroke, which is bleeding within the brain. Participants should not have had previous treatments that would affect the study's outcomes. The trial excludes those with conditions that may interfere with surgery or medical management, and those who are unlikely to follow the study protocol.

Inclusion Criteria

Glasgow Coma Score (GCS) 5 - 14

I had a specific type of brain bleed measured between 20-80 mL.

I have no or minimal disability.

Exclusion Criteria

History of drug or alcohol use or dependence that would interfere with adherence to study requirements

Known life expectancy of less than 6 months before ICH

No reasonable expectation of recovery, do-not-resuscitate (DNR), or comfort measures only before randomization

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard medical management or minimally invasive surgery plus medical management

Up to 14 days

In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

180 days

What Are the Treatments Tested in This Trial?

Interventions

• Surgical management

Trial Overview

The REACH trial is comparing two approaches: early minimally invasive surgery to remove blood from the brain versus standard medical care in ICU involving blood pressure control and other non-surgical methods aimed at preventing further bleeding or strokes.

How Is the Trial Designed?

Group I: Surgical management (MIPS) plus medical management Experimental Treatment 2 Interventions

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

Group II: medical management. Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

The Marcus Foundation

Collaborator

Trials

19

Recruited

2,200+

Citations

1.

ahajournals.org

ahajournals.org/doi/10.1161/STROKEAHA.124.048750

Surgical Management of ICH: Past, Present, and Future ...

Pooled data from STICH I, II, and STICH (trauma) have shown that patients with ICH with a Glasgow Coma Scale in the range of 9 to 12 may benefit ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5467438/

Minimally invasive surgery for intracerebral haemorrhage

Open surgical procedures to treat acute ICH have failed to show clinical benefit in large multicentre RCTs despite earlier timing, careful patient selection and ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S1878875025003274

Medical versus Surgical Treatment in Acute Intracerebral ...

The results indicated that surgical intervention significantly decreased the 3-month mortality rate among patients in comparison to conservative medical ...

4.

thelancet.com

thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00578-9/fulltext

a systematic review and network meta-analysis

We found that surgical intervention could improve functional and survival outcomes at 6 months in patients with spontaneous supratentorial ...

5.

jamanetwork.com

jamanetwork.com/journals/jamaneurology/fullarticle/2838201

Minimally Invasive Surgery vs Medical Management Alone ...

Main Outcomes and Measures The primary efficacy outcome was 180-day combined death and disability via ordinal modified Rankin Scale score (range ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12406146/

Minimally Invasive Surgery vs Medical Management Alone ...

It remains uncertain whether surgical evacuation improves functional outcomes in patients with supratentorial intracerebral hemorrhage (ICH).

7.

neurology.org

neurology.org/doi/10.1212/WNL.0000000000209714

Surgical Management for Primary Intracerebral Hemorrhage

Retrospective studies of early endoscopic surgery (within 6–8 hours of symptom onset) demonstrate safety and suggest improved outcomes. Unlike passive ...