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Minimally Invasive Soft Channel Brain Haemorrhage Evacuation for Acute Basal Ganglia Haemorrhage--Small Hemorrhage Evacuation (MIRACLE-S) | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATIONNA

Minimally Invasive Soft Channel Brain Haemorrhage Evacuation for Acute Basal Ganglia Haemorrhage--Small Hemorrhage Evacuation (MIRACLE-S)

NCT06688162•Capital Medical University

View on ClinicalTrials.gov

Summary

The objective of this study is to determine whether minimally invasive soft channel brain hemorrhage evacuation (scMIS), compared to usual care, leads to superior functional recovery as measured by utility-weighted modified Rankin Scale (UW-mRS) scores at 6 months in patients with basal ganglia intracerebral hemorrhage (ICH) of 20 ≤ volume ≤ 30 ml.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adults (18 - 80 years) ;
•2. The clinical diagnosis is acute intracerebral hemorrhage, confirmed by imaging;
•3. Onset within 48 hours, and surgery can be initiated within 48 hours;
•4. Basal ganglia hemorrhage, with a bleeding volume of 20 ≤ volume ≤ 30 ml;
•5. Reduced level of consciousness (GCS 9-14);
•6. Pre-stroke mRS score≤1 points;
•7. Systolic blood pressure \<140 mmHg before randomisation;
•8. Informed consent obtain accordingly to local regulations.

Exclusion Criteria

•1. Definite evidence the ICH is secondary to a structural abnormality in the brain (eg arteriovenous malformation, intracranial aneurysm, tumour, trauma, cerebral venous thrombosis) or previous thrombolysis or neurointerventional surgery.
•2. A high likelihood that the patient will not adhere to the study treatment and follow-up regimen.
•3. Platelet count \< 100,000, INR \> 1.4.

Locations (1)

Capital Medical University

Beijing, China

Key Dates

Start Date

January 16, 2025

Primary Completion Date

November 30, 2026

Completion Date

December 30, 2026

Last Updated

January 22, 2025

Enrollment

750

ESTIMATED participants

Conditions

Intracerebral Hemorrhage

Interventions

Usual Care

OTHER

Minimally Invasive Soft Channel Brain Haemorrhage Evacuation (scMIS)

PROCEDURE

Triple Antihypertensive Medication After Intracerebral Hemorrhage for Blood Pressure Control

NCT07458880

Intracerebral Hemorrhage

View study

RECRUITINGNA

Evaluating a Prototype CT Scan for ICH Evacuation

NCT07455201

Intracerebral Hemorrhage

View study

RECRUITING

Hemodynamic ABI Monitor

NCT06725108

Traumatic Brain Injury (TBI)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Minimally Invasive Soft Channel Brain Haemorrhage Evacuation for Acute Basal Ganglia Haemorrhage--Small Hemorrhage Evacuation (MIRACLE-S)

Inclusion Criteria

Exclusion Criteria

Triple Antihypertensive Medication After Intracerebral Hemorrhage for Blood Pressure Control

Evaluating a Prototype CT Scan for ICH Evacuation

Hemodynamic ABI Monitor

Short-term And Longer-term Cognitive Impact Of Neurochecks

Dutch Intracerebral Hemorrhage Surgery Trial

Cerebrovascular Disease: Quality of Life (CODE: QoL)