RecruitingEarly Phase 1NCT03849443

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

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


Sponsor

Rush University Medical Center

Enrollment

604 participants

Start Date

Aug 26, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • Any patient older than 18 years old
  • Scheduled for an open posterior thoracolumbar spinal fusion procedure

Exclusion Criteria14

  • 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

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Interventions

DRUGTranexamic Acid Injectable Product (1000 mg intravenous bolus)

Intravenous methods to decrease blood loss

DRUGVitamin C 250 MG Oral Tablet

Oral method of placebo

DRUGTranexamic Acid 650Mg Tablet

Oral method of treatment group


Locations(1)

Rush University Medical Center

Chicago, Illinois, United States

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NCT03849443