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NCT Number: NCT07086183

Perioperative Risk in Patients on Chronic Aspirin Undergoing Craniotomy

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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Key information

Conditions

Aneurysm Cerebral Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Aneurysm Intracranial Arterial Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sapienza University of Rome, Roma, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observation

Other

Observation of intraoperative and postoperative outcomes

Primary outcomes

  1. Postoperative Hemorrhage Rate

    Time frame: 48 hours postoperatively

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

  2. Intraoperative Blood Loss

    Time frame: From start to end of surgery

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

Secondary outcomes

  1. Subjective Bleeding Severity

    Time frame: 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)

  2. Need for Blood Transfusion

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

    The number of patients requiring intraoperative or postoperative blood transfusions.

  3. Length of hospital stay

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

    Duration of hospitalization from the day of surgery to discharge

  4. Surgical complications

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

    Incidence of surgical complications such as infection or reoperation.

Study contacts

Contact information is provided by the study sponsor or research team.

Shaun Gruenbaum, MD, PhD

CONTACT

[email protected]

904-953-2000

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Acronym: ASPRIN

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 25, 2025
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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