Can a swift surgical bundle turn the tide on bleeding strokes?
NCT ID NCT07790354
First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This trial tests whether a rapid combination of minimally invasive surgery, intensive blood pressure lowering, and a clot-stabilizing drug can improve recovery after a bleeding stroke. Adults with a moderate to large bleed in the brain are randomly assigned to receive this early bundle or standard care. The goal is to see if acting within hours reduces disability and improves functional outcomes at six months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A bundle of early minimally invasive surgery, intensive blood pressure control, and tranexamic acid
- What this could lead to
- If it works, this approach could reduce disability and improve recovery for people who have a bleeding stroke in the brain.
- What could go wrong
- The trial is large but still experimental. Surgery and blood pressure drops carry risks, and the benefit may not outweigh them for all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 878 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 years; 2. Confirmed diagnosis of spontaneous supratentorial intracerebral hemorrhage (ICH) via cerebral imaging; 3. Randomization completed within 6 hours of symptom onset (or last known normal state), with the ability to initiate MIS within 8 hours of ICH onset; 4. Hematoma volume ranging from 20 to 80 mL; 5. National Institutes of Health Stroke Scale (NIHSS) score ≥ 8; 6. Glasgow Coma Scale (GCS) score ≥ 8; 7. Provision of written informed consent (or signed by an authorized representative). Exclusion Criteria: 1. Secondary causes of hemorrhage (e.g., structural abnormalities including arteriovenous malformations, cerebral aneurysms, tumors, trauma) or hemorrhagic transformation of acute ischemic stroke; 2. Isolated intraventricular hemorrhage, or brainstem/cerebellar hemorrhage; 3. Severe chronic kidney disease or liver failure; 4. High risk of mortality within 7 days, or poor adherence to study treatment or follow-up; 5. Severe comorbidities (e.g., cancer, chronic obstructive pulmonary disease, heart failure, significant pre-stroke disability \[modified Rankin Scale (mRS) score 3-5\]) that may confound outcome assessment; 6. Other conditions judged by the investigator to be unsuitable for MIS (e.g., brain herniation, etc.); 7. Definite indications or contraindications for antihypertensive therapy of different intensities; 8. Specific contraindications to any component of the planned antihypertensive medications (e.g., patients with allergy or hypersensitivity to any ingredient); 9. Patients with contraindications to tranexamic acid (TXA), including: those allergic or hypersensitive to TXA or its excipients, patients with active thrombotic disorders, individuals with hereditary or acquired thrombophilia, patients with subarachnoid hemorrhage, and those with upper urinary tract bleeding complicated by gross hematuria, etc.; 10. Patients known at enrollment to be receiving therapeutic anticoagulation with warfarin or low-molecular-weight heparin (users of direct oral anticoagulants are eligible for inclusion and not excluded).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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