Perioperative Bleeding and Aspirin Use in Spine Surgery

Study Overview
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Brief Summary
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The investigators would like to further the current understanding of aspirin and its effects on perioperative bleeding by conducting a randomized controlled trial of spinal surgery patients receiving varying doses of aspirin or no aspirin perioperatively. The investigators hypothesize that there will be no significant difference in perioperative blood loss between the different groups.

Detailed Description
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Selected patients will be given either no aspirin, low-dose aspirin (81 mg), or high-dose aspirin (325 mg) in the perioperative period. These dosages are based on the Pharmacist's letter/Prescriber's letter which provides aspirin dosing recommendations for varying cardiovascular indications. Allocation of dosing will be based on computerized randomization in order to achieve approximately 100 patients in each group. Patient records will then be assessed for demographic characteristics, comorbidities, symptoms, functional outcome scores (Sf-12), operative time, intraoperative estimated blood loss, postoperative blood loss in drainage tubes (when applicable), cumulative blood loss, transfusion of blood products, hemoglobin level, preoperative International Normalized Ratio (INR), preoperative platelet count, hospital length of stay, and morbidity and mortality including development of NSTEMI, atrial fibrillation, surgical site infection, pulmonary embolism, and hospital 30-day readmission rates.

Official Title
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Association Between Perioperative Bleeding and Aspirin Use in Spine Surgery: A Randomized, Controlled Trial

Conditions
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Hemorrhage, Thrombosis

Intervention / Treatment
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* Drug: Acetylsalicylic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients over 18 years old, who are not taking aspirin at the time of operation as part of a current cardiovascular treatment plan, who will undergo spinal surgery from 2016-2019 in the practice of Dr. Eubanks. Exclusion Criteria: Any patient under the age of 18 and/or is already taking anticoagulant therapy for an established cardiovascular disease at the time of surgery as part of a cardiovascular therapy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No aspirin<br>Patients will not be given any Acetylsalicylic acid in the perioperative period. | |
| Experimental: Low-dose aspirin<br>Patients will be given low-dose Acetylsalicylic acid (81 mg) in the perioperative period. | Drug: Acetylsalicylic acid<br>* Patients will receive different doses of aspirin perioperatively to assess bleeding association.<br>* Other names: aspirin;|
| Experimental: High-dose aspirin<br>Patients will be given high-dose Acetylsalicylic acid (325 mg) in the perioperative period. | Drug: Acetylsalicylic acid<br>* Patients will receive different doses of aspirin perioperatively to assess bleeding association.<br>* Other names: aspirin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemorrhage: Amount of blood loss | Amount of blood loss from the operation will be recorded | Intraoperative | 
| Hemorrhage: Amount of blood loss | Blood loss from drainage tube when applicable | 48 hours Postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Transfusion: Amount of blood products transfused | Amount of blood products transfused when applicable | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bleeding, Aspirin, Spine, Surgery