Brain bleed breakthrough? Two-Drug combo aims to stabilize blood pressure and save lives
NCT ID NCT07695220
First seen Jul 10, 2026 · Last updated Jul 10, 2026
Summary
This trial investigates whether giving two drugs—remifentanil and dexmedetomidine—soon after a spontaneous brain hemorrhage can safely lower blood pressure and improve recovery. The study includes adults with a brain bleed who have high blood pressure and are treated within six hours of symptoms starting. Researchers will compare this intensive blood pressure-lowering strategy to standard care, measuring disability and survival at 90 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- remifentanil and dexmedetomidine
- What this could lead to
- If successful, this approach could offer a new, more stable way to control blood pressure after a brain bleed, potentially reducing disability and death.
- What could go wrong
- This is an early-stage trial, and the combination of drugs may cause side effects like low blood pressure or breathing problems. It is not yet proven to improve outcomes.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 1,116 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
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. Acute intracerebral hemorrhage confirmed by non-contrast head computed tomography. 3. Symptom onset ≤ 6 h before randomization. 4. At least two systolic blood pressure ≥ 150 mmHg separated by \> 2 min prior to randomization. 5. Admission to a monitored unit capable of active acute care (e.g., acute stroke unit, emergency department, or intensive care unit). 6. Written informed consent provided by the patient or legally authorized representative. Exclusion Criteria: 1. Contraindication to intensive blood-pressure lowering (e.g., severe stenosis of carotid, vertebral, or cerebral arteries; Moyamoya disease; Takayasu arteritis; critical aortic stenosis). 2. Clear evidence that the hemorrhage is secondary to a structural brain abnormality (arteriovenous malformation, aneurysm, tumor, trauma, infarct) or recent thrombolysis. 3. Ischemic stroke within the preceding 30 days. 4. Very high probability of death within 24 h based on clinical and/or radiologic criteria. 5. Known advanced dementia or pre-stroke disability (pre- modified Rankin Scale score ≥ 3). 6. Coagulopathy due to medication or hematologic disorder. 7. Comorbid conditions that would interfere with outcome assessment or follow-up (e.g., active malignancy, end-stage organ failure). 8. Known hypersensitivity to remifentanil or dexmedetomidine. 9. Pregnancy or lactation. 10. Concurrent participation in another investigational drug or device trial. 11. Patient or legally authorized representative unwilling or unable to provide informed consent, or judged unlikely to comply with study procedures or follow-up.
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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
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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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