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Brain tumor surgery: new drug may cut stroke risk

NCT ID NCT07520370

Disease control Sponsor: Beijing Tiantan Hospital Source: ClinicalTrials.gov ↗

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether the anti-inflammatory drug ulinastatin can prevent strokes in people having brain tumor removal. About 1,370 patients will receive either ulinastatin or a placebo before and after surgery. The goal is to see if the drug lowers the chance of having a stroke within a week after the operation.

What this could mean

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

Active substance
Ulinastatin (an anti-inflammatory drug given intravenously)
What this could lead to
If it works, this could provide a simple way to reduce stroke risk after brain tumor surgery, improving recovery and safety.
What could go wrong
This is a single-center trial that hasn't started yet. The drug may not reduce strokes, and there is a small risk of allergic reactions or side effects from the drug.

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 1,370 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

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 75 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: * American Society of Anesthesiologists physical status I-III * Scheduled for elective supratentorial tumor resection * Written informed consent provided by the patient or a legally authorized representative Exclusion Criteria: * Known allergy to ulinastatin or any of its excipients * Severe preoperative hepatic or renal dysfunction (Child-Pugh class C or estimated glomerular filtration rate \< 30 mL/min/1.73 m²) * Presence of severe coagulation disorders * Severe pre-existing neurological deficits, defined as cognitive impairment based on the Mini-Mental State Examination (MMSE) according to the patient's educational level (illiterate \< 17, primary school education \< 20, secondary school education or higher \< 24), language impairment preventing cooperation with psychiatric assessment, or modified Rankin Scale (mRS) score \> 3 * Pregnancy or breastfeeding * Concurrent participation in another clinical trial that may interfere with the results of this study

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Conditions

The condition(s) this trial relates to.

brain cancer brain neoplasm stroke disorder

As listed by the trial registrant

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

Brain tumor Perioperative anti-inflammatory therapy Stroke Ulinastatin

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.