Aneurysm CerebralASPRINNCT07086183
Perioperative Risk in Patients on Chronic Aspirin Undergoing Craniotomy
An observational study of Aneurysm Cerebral, run by Mayo Clinic at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysm Cerebral
- What is being tested?
- Observation
- How many people
- 100 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Dec 2026to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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)
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
United States1 site
Mayo Clinic Florida
Jacksonville, Florida, 32224
Shaun Gruenbaum, MD, PhD, 904-953-2000, gruenbaum.shaun@mayo.edu
Shaun Gruenbaum, MD, PhD
Italy1 site
Sapienza University of Rome
Roma, 00185
Federico Bilotta, MD, PhD, +39 06 49911, bilotta@tiscali.it
Federico Bilotta, MD, PhD
Russia1 site
Burdenko National Medical Research Center of Neurosurgery
Moscow, 125047
Alexander Kulikov, MD, PhD, +7 499 972-86-68, akulikov@nsi.ru
Alexander Kulikov, MD, PhD
About this study
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)
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?
Read more
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.
- Conditions
- Aneurysm Cerebral
- Being tested
- Observation
- Keywords
- craniotomy, aneurysm clipping, aspirin, postoperative bleeding
- Medical subject headings
- Intracranial Aneurysm, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Observation of intraoperative and postoperative outcomes
| Study group | Role | What they receive |
|---|---|---|
| Chronic aspirin | Patients on chronic aspirin Receives: Other: Observation | |
| No aspirin | Patients who are not on aspirin Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Hemorrhage Rate
The incidence of postoperative hemorrhage detected on CT scans within 48 hours after surgery.
Measured: 48 hours postoperatively
Intraoperative Blood Loss
Measured by the change in hemoglobin and hematocrit levels from preoperative baseline to immediate postoperative period.
Measured: From start to end of surgery
Secondary outcomes (4)
Subjective Bleeding Severity
Rated by the operating surgeon using a standardized 5-point Likert scale (0 = no bleeding to 4 = severe bleeding)
Measured: From start to end of surgery
Need for Blood Transfusion
The number of patients requiring intraoperative or postoperative blood transfusions.
Measured: 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
Measured: From end of surgery to day of discharge, up to 7 days
Surgical complications
Incidence of surgical complications such as infection or reoperation.
Measured: From end of surgery to day of discharge, up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysm CerebralStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaun Gruenbaum, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086183
- Sponsor's protocol ID
- 25-006605
- Acronym
- ASPRIN
- Status last verified
- Jan 2026
- First submitted
- 18 Jul 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07086183
- Acronym / sponsor ID
- ASPRIN / 25-006605
- Conditions
- Aneurysm Cerebral
- Keywords
- craniotomy, aneurysm clipping, aspirin, postoperative bleeding
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic aspirin | – | Other: ObservationPatients on chronic aspirin |
| No aspirin | – | Other: ObservationPatients who are not on aspirin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationObservation of intraoperative and postoperative outcomes | Other | Chronic aspirin, No aspirin |
Primary outcome
Postoperative Hemorrhage Rate
Time frame: 48 hours postoperatively
The incidence of postoperative hemorrhage detected on CT scans within 48 hours after surgery.
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Aneurysm Cerebral
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
Not yet recruitingPhase 1/2
Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
Aneurysmal Subarachnoid Hemorrhage
RecruitingObservational study
A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms
Intracranial Aneurysm
Not yet recruiting
Effect of Bilateral Greater Occipital Nerve Block on Headache After Intracranial Aneurysm Coiling
Intracranial Aneurysm, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysm Cerebral, run by Mayo Clinic at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Italy, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shaun Gruenbaum, MD, PhD (904-953-2000, gruenbaum.shaun@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Hemorrhage Rate (time frame: 48 hours postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.