NCT02807441

Perioperative Bleeding and Aspirin Use in Spine Surgery

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Hemorrhage
• Thrombosis

Interventions

Type	Name	Description
DRUG	Acetylsalicylic acid	Patients will receive different doses of aspirin perioperatively to assess bleeding association.

Timeline

• Start date: 2016-07-01
• Primary completion: 2019-07-01
• Completion: 2019-12-01
• First posted: 2016-06-21
• Last updated: 2021-10-11

Locations

1 site across 1 country: United States