Health TrialsbyHealthPanel

Perioperative Risk in Patients on Chronic Aspirin Undergoing Craniotomy

ConditionAneurysm Cerebral
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

Patients scheduled for elective craniotomy for cerebral aneurysm clipping Recruited from three international sites: Mayo Clinic Florida (USA) Burdenko National Medical Research Center of Neurosurgery (Russia) Sapienza University of Rome (Italy)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observation

    Other intervention

    Observation of intraoperative and postoperative outcomes

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Chronic aspirin1 intervention
Group B: No aspirin1 intervention

Trial outcomes

Primary outcomes

1

Postoperative Hemorrhage Rate

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

Time frame
48 hours postoperatively
2

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

1

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
2

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
3

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
4

Surgical complications

Incidence of surgical complications such as infection or reoperation.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: