Brain TumorNCT07520370
Effect of Perioperative Ulinastatin on Postoperative Stroke in Patients With Brain Tumor
A study testing Ulinastatin and 0.9% Saline in people with Brain Tumor and Stroke, run by Beijing Tiantan Hospital.
Trial summary
Previous studies have shown that the incidence of postoperative stroke, particularly covert stroke, is high following brain tumor resection and is closely associated with inflammatory responses and disruption of the blood-brain barrier. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Tumor, Stroke, Ulinastatin
- What is being tested?
- Ulinastatin and 0.9% Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,370 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Perioperative Anti-inflammatory Therapy on Postoperative Stroke in Patients Undergoing Brain Tumor Resection: A Randomized Controlled Trial
Previous studies have shown that the incidence of postoperative stroke, particularly covert stroke, is high following brain tumor resection and is closely associated with inflammatory responses and disruption of the blood-brain barrier. Ulinastatin, a broad-spectrum protease inhibitor, exerts multiple pharmacological effects including anti-inflammatory activity and protection of the blood-brain barrier; however, its efficacy in preventing postoperative stroke has not been validated by prospective studies. Therefore, a single-center, randomized, double-blind, placebo-controlled trial will be conducted, enrolling 1,370 patients undergoing elective supratentorial tumor resection. Patients will receive ulinastatin (6,000 IU/kg) or normal saline both before and after surgery. This study aims to evaluate whether ulinastatin reduces the incidence of postoperative stroke, thereby providing high-level evidence for perioperative brain protection in patients undergoing brain tumor surgery.
- Being tested
- Ulinastatin, 0.9% Saline
- Medical subject headings
- Brain Neoplasms, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UlinastatinDrug
Ulinastatin at a dose of 6,000 IU/kg was diluted in 100 mL of normal saline and administered intravenously over 30 minutes after anesthesia induction (30 minutes before skin incision) and again immediately after surgery.
0.9% SalineDrug
An equal volume of 0.9% saline was administered intravenously at the same time points, following the same regimen.
| Study group | Role | What they receive |
|---|---|---|
| Ulinastatin group | Active comparator | The ulinastatin group patients will be received ulinastatin intraoperatively. Receives: Drug: Ulinastatin |
| Placebo group | Placebo comparator | The placebo group patients will be received 0.9% saline intraoperatively. Receives: Drug: 0.9% Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative stroke (including overt and covert stroke) within 7 days after surgery in patients undergoing brain tumor resection.
Assessment was performed using cranial magnetic resonance imaging with diffusion-weighted imaging sequences.
Measured: Evaluation was conducted between postoperative days 3 and 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuming Peng, Beijing Tiantan Hospital
- Investigators
- Yuming Peng, MD,Ph.D, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520370
- Sponsor's protocol ID
- 20260402
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Anti-inflammatory Therapy on Postoperative Stroke in Patients Undergoing Brain Tumor Resection: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07520370
- Acronym / sponsor ID
- 20260402
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,370 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous studies have shown that the incidence of postoperative stroke, particularly covert stroke, is high following brain tumor resection and is closely associated with inflammatory responses and disruption of the blood-brain barrier. Ulinastatin, a broad-spectrum protease inhibitor, exerts multiple pharmacological effects including anti-inflammatory activity and protection of the blood-brain barrier; however, its efficacy in preventing postoperative stroke has not been validated by prospective studies. Therefore, a single-center, randomized, double-blind, placebo-controlled trial will be conducted, enrolling 1,370 patients undergoing elective supratentorial tumor resection. Patients will receive ulinastatin (6,000 IU/kg) or normal saline both before and after surgery. This study aims to evaluate whether ulinastatin reduces the incidence of postoperative stroke, thereby providing high-level evidence for perioperative brain protection in patients undergoing brain tumor surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ulinastatin group | Active comparator | Drug: UlinastatinThe ulinastatin group patients will be received ulinastatin intraoperatively. |
| Placebo group | Placebo comparator | Drug: 0.9% SalineThe placebo group patients will be received 0.9% saline intraoperatively. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UlinastatinUlinastatin at a dose of 6,000 IU/kg was diluted in 100 mL of normal saline and administered intravenously over 30 minutes after anesthesia induction (30 minutes before skin incision) and again immediately after surgery. | Drug | Ulinastatin group |
| 0.9% SalineAn equal volume of 0.9% saline was administered intravenously at the same time points, following the same regimen. | Drug | Placebo group |
Primary outcome
Incidence of postoperative stroke (including overt and covert stroke) within 7 days after surgery in patients undergoing brain tumor resection.
Time frame: Evaluation was conducted between postoperative days 3 and 7.
Assessment was performed using cranial magnetic resonance imaging with diffusion-weighted imaging sequences.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuming Peng, MD,Ph.D principal investigator
Beijing Tiantan Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Ulinastatin and 0.9% Saline in people with Brain Tumor and Stroke, run by Beijing Tiantan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuming Peng, MD,Ph.D (8610-59976658, florapym766@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative stroke (including overt and covert stroke) within 7 days after surgery in patients undergoing brain tumor resection. (time frame: Evaluation was conducted between postoperative days 3 and 7.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.