Perioperative Risk in Patients on Chronic Aspirin Undergoing Craniotomy

NCT ID: NCT07086183

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-12-01

Study Completion Date

2027-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Aneurysm Cerebral

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Chronic aspirin

Patients on chronic aspirin

Observation

Intervention Type OTHER

Observation of intraoperative and postoperative outcomes

No aspirin

Patients who are not on aspirin

Observation

Intervention Type OTHER

Observation of intraoperative and postoperative outcomes

Interventions

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Observation

Observation of intraoperative and postoperative outcomes

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Shaun Gruenbaum

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mayo Clinic Florida

Jacksonville, Florida, United States

Site Status

Sapienza University of Rome

Roma, , Italy

Site Status

Burdenko National Medical Research Center of Neurosurgery

Moscow, , Russia

Site Status

Countries

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United States Italy Russia

Central Contacts

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Shaun Gruenbaum, MD, PhD

Role: CONTACT

904-953-2000

Facility Contacts

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Shaun Gruenbaum, MD, PhD

Role: primary

904-953-2000

Federico Bilotta, MD, PhD

Role: primary

+39 06 49911

Alexander Kulikov, MD, PhD

Role: primary

+7 499 972-86-68

Other Identifiers

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25-006605

Identifier Type: -

Identifier Source: org_study_id

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