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Starting soon Observational

Perioperative Risk in Patients on Chronic Aspirin Undergoing Craniotomy

NCT07086183 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2026-12-01
Last updated
2026-01-07

Condition(s) studied

Aneurysm Cerebral

Investigational drug(s) / intervention(s)

Observation

Observation: Observation of intraoperative and postoperative outcomes

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Postoperative Hemorrhage Rate — 48 hours postoperatively
    The incidence of postoperative hemorrhage detected on CT scans within 48 hours after surgery.
  • Intraoperative Blood Loss — From start to end of surgery
    Measured by the change in hemoglobin and hematocrit levels from preoperative baseline to immediate postoperative period.

Trial sites (3)

FacilityCityRegionStatus
Mayo Clinic Florida Jacksonville Florida
Sapienza University of Rome Roma Italy
Burdenko National Medical Research Center of Neurosurgery Moscow Russia
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07086183 on ClinicalTrials.gov ↗ ← All trials in Italy