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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic aspirin | Patients on chronic aspirin |
| |
| No aspirin | Patients who are not on aspirin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation | Other | Observation of intraoperative and postoperative outcomes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Hemorrhage Rate | The incidence of postoperative hemorrhage detected on CT scans within 48 hours after surgery. | 48 hours postoperatively |
| Intraoperative Blood Loss | Measured by the change in hemoglobin and hematocrit levels from preoperative baseline to immediate postoperative period. | From start to end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Bleeding Severity | Rated by the operating surgeon using a standardized 5-point Likert scale (0 = no bleeding to 4 = severe bleeding) | From start to end of surgery |
| Need for Blood Transfusion |
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Inclusion Criteria:
Exclusion Criteria:
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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)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shaun Gruenbaum, MD, PhD | Contact | 904-953-2000 | gruenbaum.shaun@mayo.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| D019106 | Postoperative Hemorrhage |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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The number of patients requiring intraoperative or postoperative blood transfusions.
| 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 | From end of surgery to day of discharge, up to 7 days |
| Surgical complications | Incidence of surgical complications such as infection or reoperation. | From end of surgery to day of discharge, up to 7 days |
| Sapienza University of Rome | Roma | 00185 | Italy |
|
| Burdenko National Medical Research Center of Neurosurgery | Moscow | 125047 | Russia |
|
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |