Single Versus Multi-Dose Oral and Intravenous Tranexamic Acid Patients at High Risk for Blood Transfusion After Spine Surgery

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

As tranexamic acid (TXA) becomes more prevalent, all patients are receiving the same dose and method of delivery regardless of their pre-operative risk of transfusion. Therefore, the aim of the study is to determine whether or not repeated dosing of oral or different method of delivery like intravenous (IV) TXA reduces the postoperative reduction in hemoglobin, hematocrit, number of transfusions, and postoperative blood loss following open spine surgery. The regimen that utilizes multiple doses of oral TXA will significantly minimize post-operative blood loss and transfusion requirements compared to the use of a single dose regimen. Furthermore, oral TXA will be as efficacious as intravenous delivery of TXA.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rush University Medical Center
• Treatments: Ascorbic Acid; Tranexamic Acid

Criteria

Inclusion Criteria:

• Any patient older than 18 years old

• Scheduled for an open posterior thoracolumbar spinal fusion procedure

Exclusion Criteria:

• Allergy to TXA

• Acquired disturbances of color vision

• Refusal of blood products

• Pre-op use of anticoagulant therapy within five days before surgery

• History of arterial or venous thromboembolic disease (such as DVT, PE, CVA, TIA)

• Pregnancy

• Breastfeeding

• Severe ischemic heart disease [New York Heart Association Class III or IV]

• Previous myocardial infarction

• Severe pulmonary disease

• Renal impairment

• Hepatic failure

• Patients who decline to participate

• Intolerance or sensitivity to Vitamin C