Perioperative Risk in Patients on Chronic Aspirin Undergoing Craniotomy

N/ANot Yet RecruitingNCT07086183

Mayo Clinic100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Aneurysm Cerebral

Interventions

ObservationOTHER

Observation of intraoperative and postoperative outcomes

Medical Language ↔ Plain English

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)

Mayo Clinic Florida

Jacksonville, Florida, United States

Sapienza University of Rome

Roma, Italy

Burdenko National Medical Research Center of Neurosurgery

Moscow, Russia

Outcomes

Primary Outcomes

Postoperative Hemorrhage Rate

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

Time frame: 48 hours postoperatively

Intraoperative Blood Loss

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

Time frame: From start to end of surgery

Secondary Outcomes

Subjective Bleeding Severity

Rated by the operating surgeon using a standardized 5-point Likert scale (0 = no bleeding to 4 = severe bleeding)

Time frame: From start to end of surgery

Need for Blood Transfusion

The number of patients requiring intraoperative or postoperative blood transfusions.

Time frame: From start of surgery to day of discharge, up to 7 days

Length of hospital stay

Duration of hospitalization from the day of surgery to discharge

Time frame: From end of surgery to day of discharge, up to 7 days

Surgical complications

Incidence of surgical complications such as infection or reoperation.