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Robot-Guided surgery plus Clot-Busting drug aims to improve brain bleed recovery

NCT ID NCT03957707

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times

Summary

This study tests whether a combination of stereotactic (computer-guided) surgery and a clot-dissolving drug can help people recover from a deep brain hemorrhage. The trial enrolls 380 adults with small-to-moderate bleeds in the basal ganglia who have significant disability. The goal is to see if this precise, personalized approach leads to better functional independence compared to standard care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
stereotactic surgery plus thrombolytic agent
What this could lead to
If successful, this could establish a standard minimally invasive procedure to improve functional independence after a deep brain hemorrhage.
What could go wrong
This is a mid-stage trial without a placebo control, and results may not apply to larger bleeds or all patients. Surgery carries risks of infection, rebleeding, or incomplete clot removal.

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

380 people

The number who actually took part.

Started

Jan 2019

Finished

Oct 2025

Lead sponsor

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

18 to 70 years

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. Diagnosis of spontaneous basal ganglia hemorrhage by imaging (CT, CTA, etc.) with a hematoma volume of 10-30 mL calculated by ABC/2 formula and Glasgow Coma Scale score ≥ 9. 2. With dysfunction such as hematoma-related motor aphasia, sensory aphasia, hemiplegic limb muscle strength ≤ grade 3 or NIHSS score ≥ 15 points. 3. Hematoma stability shown by a CT scan at least 6 hours after the diagnostic CT (hematoma volume increase \< 5 ml by ABC/2 formula). 4. Diagnostic CT scan should be obtained within 24 hours after the onset of symptoms. Cases with unclear onset time should be excluded. 5. Randomization within 72 hours after diagnostic CT. 6. Surgery should be performed within 72 hours after onset. 7. SBP \<180 mmHg maintained for 6 hours prior to randomization. 8. Age between 18-70 years old. 9. mRS score ≤ 1 in past medical history. 10. Patients who are suitable and willing to be randomized to "puncture aspiration + urokinase" or conservative medical treatment. Exclusion Criteria: 1. Hematoma involves other structures such as the thalamus and midbrain. 2. Mass effect or hydrocephalus due to intraventricular hemorrhage. 3. Imaging-based diagnosis of cerebrovascular abnormalities such as ruptured aneurysm, arteriovenous malformation (AVM) and moyamoya disease as well as hemorrhagic transformation of ischemic infarct and recent recurrence (within 1 year) of cerebral hemorrhage. 4. Manifestation of early stage cerebral herniation such as ipsilateral pupil changes and midline shift exceeding 1 cm. 5. Patients with unsteady hematoma or with progression to intracranial hypertension syndrome. 6. Patients with any irreversible coagulopathy or known coagulation disorders; platelet count \<100,000; INR \> 1.4. 7. Patients requiring long-term use of anticoagulants. 8. Patients taking dabigatran, apixaban and/or rivaroxaban (or similar drugs of the same category) before symptoms arise. 9. Bleeding in other sites, including retroperitoneal, gastrointestinal, genitourinary or respiratory tract bleeding; superficial or skin surface bleeding mainly occurring in the vascular puncture site or transvenous approach (eg. arterial puncture, venous incision, etc. ) or in the recent surgical site. 10. May be pregnant in the near future or already pregnant. 11. Previously enrolled in this study. 12. Participating in other interventional medical research or clinical trials at the same time. Patients enrolled in observational, natural history and/or epidemiological studies (without intervention) are eligible for this trial. 13. Patients with an expected survival of less than 6 months. 14. Patients with severe co-morbidity (including hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrine, immune and/or hematological disorders) which may affect the outcome assessment. 15. Patients with mechanical heart valve. Biological valves are acceptable. 16. Patients with risk of embolism (including a history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis or subacute bacterial endocarditis). Atrial fibrillation without mitral stenosis is acceptable. 17. Investigators believe co-morbidities would be detrimental to the patient when the study begins. 18. Patients difficult to follow up or with poor compliance due to various reasons (such as geographical and social factors, drug or alcohol abuse, etc.). 19. Patient or his or her legal guardian/representative is unable or unwilling to give the written informed consent. 20. Patient is in a condition that is not suitable for "puncture aspiration + urokinase" treatment.

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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.

Contacts and locations

Locations

  • the Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009, China