Perioperative Risk in Patients on Chronic Aspirin Undergoing Craniotomy

NCT07086183 — Not yet recruiting, 100 participants, Mayo Clinic

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

Registry	NCT07086183, acronym ASPRIN
Status	Not yet recruiting
Study type	Observational
Enrollment	100 (Estimated)
Sponsor	Mayo Clinic (Other)
Conditions	Aneurysm Cerebral
Interventions	Observation (Other)
Dates	start 2026-12-01 (estimated), primary completion 2027-12-01 (estimated), completion 2027-12-01 (estimated), first posted 2025-07-25, last updated 2026-01-07
Locations	3 sites in United States, Italy, Russia

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Chronic aspirin		Other: Observation	Patients on chronic aspirin
No aspirin		Other: Observation	Patients who are not on aspirin

Observation (Other): Observation of intraoperative and postoperative outcomes

+Outcome measures

Primary outcomes

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.

Secondary outcomes

Subjective Bleeding Severity [From start to end of surgery]: Rated by the operating surgeon using a standardized 5-point Likert scale (0 = no bleeding to 4 = severe bleeding)
Need for Blood Transfusion [From start of surgery to day of discharge, up to 7 days]: The number of patients requiring intraoperative or postoperative blood transfusions.
Length of hospital stay [From end of surgery to day of discharge, up to 7 days]: Duration of hospitalization from the day of surgery to discharge
Surgical complications [From end of surgery to day of discharge, up to 7 days]: Incidence of surgical complications such as infection or reoperation.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (3)

Facility	City	Country
Mayo Clinic Florida	Jacksonville, Florida	United States
Sapienza University of Rome	Roma	Italy
Burdenko National Medical Research Center of Neurosurgery	Moscow	Russia

My Notes

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