Perioperative Bleeding and Aspirin Use in Spine Surgery

Phase 3

Withdrawn

• Conditions: Hemorrhage; Thrombosis
• Interventions: Drug: Acetylsalicylic acid

• Registration Number: NCT02807441
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-06-20
• Study First Posted: 2016-06-21
• Study Start: 2016-07
• Primary Completion: 2019-07
• Study Completion: 2019-12
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-03
• Last Update Posted: 2021-10-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-dose aspirin	Acetylsalicylic acid	Patients will be given high-dose Acetylsalicylic acid (325 mg) in the perioperative period.
Low-dose aspirin	Acetylsalicylic acid	Patients will be given low-dose Acetylsalicylic acid (81 mg) in the perioperative period.

Primary Outcome Measures

Name	Time	Method
Hemorrhage: Amount of blood loss	48 hours Postoperative	Blood loss from drainage tube when applicable

Secondary Outcome Measures

Name	Time	Method
Blood Transfusion: Amount of blood products transfused	Intraoperative	Amount of blood products transfused when applicable

Trial Locations

Locations (1)

University Hospitals Case Medical Center; 🇺🇸 Cleveland, Ohio, United States