Surgical vs Medical Management for Intracerebral Hemorrhage

(REACH Trial)

Recruiting at 2 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

Trial Summary

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.

What data supports the effectiveness of surgical treatment for intracerebral hemorrhage?

The research suggests that surgical treatment for intracerebral hemorrhage may lead to better outcomes in terms of independence, as 43.3% of patients in the surgical group were independent compared to 23.4% in the medical group, although the difference was not statistically significant. ^{1 2 3 4 5}

Is surgical management for intracerebral hemorrhage generally safe?

Surgical management for intracerebral hemorrhage has been studied, and while minimally invasive techniques show some promise, traditional open surgery has not demonstrated clear safety benefits. There is a high risk of complications, and the safety of these procedures can vary depending on the specific surgical approach used. ^{6 7 8 9 10}

How does surgical management differ from other treatments for intracerebral hemorrhage?

Surgical management for intracerebral hemorrhage involves physically removing the blood clot from the brain, which can be done through traditional open surgery or less invasive methods like endoscopy. This approach is different from medical management, which typically involves medications to manage symptoms and prevent further bleeding, without directly removing the clot. ^{2 5 11 12 13}

What is the purpose of this trial?

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.

Research Team

Alex Hall, DHSc

Principal Investigator

Emory University

Gustavo Pradilla, MD

Principal Investigator

Emory University

Jonathan Ratcliff, MD

Principal Investigator

Emory University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Bangladesh pubmed.ncbi.nlm.nih.gov

Surgery for primary intracerebral haemorrhage: is it safe and effective? [2019]

2. Italy pubmed.ncbi.nlm.nih.gov

[Spontaneous cerebral hematomas. Treatment and follow-up studies]. [2006]

3. Japan pubmed.ncbi.nlm.nih.gov

The impact of different surgical treatments for intracerebral hemorrhage on functional outcomes during the convalescent stage. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Indications for surgical treatment of intracerebral hemorrhage. [2004]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Conservative versus operative treatment in supratentorial intracerebral hemorrhage - A survey among neurosurgeons and neurologists in Germany. [2020]

6. Germany pubmed.ncbi.nlm.nih.gov

Surgical management of spontaneous intracerebral hemorrhage: insights from randomized controlled trials. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Early surgical treatment for supratentorial intracerebral hemorrhage: a randomized feasibility study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Modern Approaches to Evacuating Intracerebral Hemorrhage. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Iatrogenic intracerebral hemorrhage. [2005]

10. England pubmed.ncbi.nlm.nih.gov

Minimally invasive endoscopic hematoma evacuation vs best medical management for spontaneous basal-ganglia intracerebral hemorrhage. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Surgical Management of Supratentorial Intracerebral Hemorrhages: Endoscopic Versus Open Surgery. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Minimally invasive surgery treatment for the patients with spontaneous supratentorial intracerebral hemorrhage (MISTICH): protocol of a multi-center randomized controlled trial. [2021]

13. Italy pubmed.ncbi.nlm.nih.gov

Considerations about the surgical indication of the spontaneous cerebral haematomas. [2017]