Perioperative Bleeding and Aspirin Use in Spine Surgery — ASA  

Thrombosis Clinical Trial

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

Status Withdrawn

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Hemorrhage
• Thrombosis

• NCT number: NCT02807441
• Study type: Interventional
• Source: University Hospitals Cleveland Medical Center
• Status: Withdrawn
• Phase: Phase 3
• Start date: July 2016
• Completion date: December 2019