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Perioperative Risk in Patients on Chronic Aspirin Undergoing Craniotomy

Assessing Surgical Perioperative rIsk in Patients on chRonic aspIrN Therapy Undergoing Elective Craniotomy for Aneurysm Clipping: a Prospective Multi-center Observational Study (ASPIRIN)

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07086183
Acronym
ASPRIN
Enrollment
100
Registered
2025-07-25
Start date
2026-12-01
Completion date
2027-12-01
Last updated
2026-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysm Cerebral

Keywords

craniotomy, aneurysm clipping, aspirin, postoperative bleeding

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.

Interventions

OTHERObservation

Observation of intraoperative and postoperative outcomes

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Hemorrhage Rate48 hours postoperativelyThe incidence of postoperative hemorrhage detected on CT scans within 48 hours after surgery.
Intraoperative Blood LossFrom start to end of surgeryMeasured by the change in hemoglobin and hematocrit levels from preoperative baseline to immediate postoperative period.

Secondary

MeasureTime frameDescription
Subjective Bleeding SeverityFrom start to end of surgeryRated by the operating surgeon using a standardized 5-point Likert scale (0 = no bleeding to 4 = severe bleeding)
Need for Blood TransfusionFrom start of surgery to day of discharge, up to 7 daysThe number of patients requiring intraoperative or postoperative blood transfusions.
Length of hospital stayFrom end of surgery to day of discharge, up to 7 daysDuration of hospitalization from the day of surgery to discharge
Surgical complicationsFrom end of surgery to day of discharge, up to 7 daysIncidence of surgical complications such as infection or reoperation.

Countries

Italy, Russia, United States

Contacts

Primary ContactShaun Gruenbaum, MD, PhD
gruenbaum.shaun@mayo.edu904-953-2000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026