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Brain bleed breakthrough? Two-Drug combo aims to stabilize blood pressure and save lives

NCT ID NCT07695220

Disease control Sponsor: The Third Affiliated Hospital of Southern Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 1,116 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

intracerebral hemorrhage

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intracerebral hemorrhage

How to take part

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  1. The official record

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