NCT07086183

Brief Summary

This study is looking at how taking aspirin regularly affects bleeding during and after brain surgery. Specifically, it focuses on patients who are having elective surgery to clip a brain aneurysm. Aspirin is commonly used to prevent heart attacks and strokes, but it can also increase the risk of bleeding. Doctors often face a tough decision: should patients stop taking aspirin before surgery to reduce bleeding risk, or continue it to prevent blood clots? To help answer this question, researchers will observe 100 patients, some who take aspirin regularly and some who don't, at hospitals in the U.S., Russia, and Italy. They will not change any treatments but will collect information about bleeding during surgery, blood test results, and CT scans after surgery. The goal is to better understand the risks of continuing aspirin and to help doctors make safer decisions for future patients.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
12mo left

Started Dec 2026

Shorter than P25 for all trials

Geographic Reach
3 countries

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 25, 2025

Completed
1.4 years until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

July 18, 2025

Last Update Submit

January 5, 2026

Conditions

Aneurysm Cerebral

Keywords

craniotomyaneurysm clippingaspirinpostoperative bleeding

Outcome Measures

Primary Outcomes (2)

  • Postoperative Hemorrhage Rate

    The incidence of postoperative hemorrhage detected on CT scans within 48 hours after surgery.

    48 hours postoperatively

  • Intraoperative Blood Loss

    Measured by the change in hemoglobin and hematocrit levels from preoperative baseline to immediate postoperative period.

    From start to end of surgery

Secondary Outcomes (4)

  • Subjective Bleeding Severity

    From start to end of surgery

  • Need for Blood Transfusion

    From start of surgery to day of discharge, up to 7 days

  • Length of hospital stay

    From end of surgery to day of discharge, up to 7 days

  • Surgical complications

    From end of surgery to day of discharge, up to 7 days

Study Arms (2)

Chronic aspirin

Patients on chronic aspirin

Other: Observation

No aspirin

Patients who are not on aspirin

Other: Observation

Interventions

ObservationOTHER

Observation of intraoperative and postoperative outcomes

Chronic aspirinNo aspirin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for elective craniotomy for cerebral aneurysm clipping Recruited from three international sites: Mayo Clinic Florida (USA) Burdenko National Medical Research Center of Neurosurgery (Russia) Sapienza University of Rome (Italy)

You may qualify if:

  • Age \> or = 18 years old
  • Patients willing to participate and provide an informed consent
  • Patients undergoing elective craniotomy for cerebral aneurysm clipping
  • Patients on chronic low-dose (75-100 mg) aspirin daily (aspirin group) or not on aspirin therapy for at least 7 days (control group) preoperatively.

You may not qualify if:

  • Emergency craniotomy
  • Use of other antiplatelet or anticoagulant medications within 7 days prior to surgery
  • Known bleeding disorders (e.g. hemophilia, thrombocytopenia)
  • History of intracranial hemorrhage unrelated to aneurysm
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Sapienza University of Rome

Roma, 00185, Italy

Location

Burdenko National Medical Research Center of Neurosurgery

Moscow, 125047, Russia

Location

MeSH Terms

Conditions

Intracranial AneurysmPostoperative Hemorrhage

Interventions

Observation

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative Complications

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

Shaun Gruenbaum, MD, PhD

CONTACT

904-953-2000gruenbaum.shaun@mayo.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 18, 2025

First Posted

July 25, 2025

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)US(1)RU(1)