Perioperative Risk in Patients on Chronic Aspirin Undergoing Craniotomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observation.
- Who it may be relevant to
- Registry conditions: Aneurysm Cerebral. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Italy, Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessing Surgical Perioperative rIsk in Patients on chRonic aspIrN Therapy Undergoing Elective Craniotomy for Aneurysm Clipping: a Prospective Multi-center Observational Study (ASPIRIN)
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.
Interventions
- Other Observation
Observation of intraoperative and postoperative outcomes
Primary outcome measures
- Postoperative Hemorrhage Rate [Time frame: 48 hours postoperatively]
- Intraoperative Blood Loss [Time frame: From start to end of surgery]
Secondary outcome measures (4)
- Subjective Bleeding Severity [Time frame: From start to end of surgery]
- Need for Blood Transfusion [Time frame: From start of surgery to day of discharge, up to 7 days]
- Length of hospital stay [Time frame: From end of surgery to day of discharge, up to 7 days]
- Surgical complications [Time frame: From end of surgery to day of discharge, up to 7 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mayo Clinic Florida — Jacksonville
Italy · 1 center
- Sapienza University of Rome — Roma
Russia · 1 center
- Burdenko National Medical Research Center of Neurosurgery — Moscow
Identifiers
NCT: NCT07086183 · 25-006605