RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-08-26
Study Completion:2026-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03849443

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Any patient older than 18 years old
  2. * Scheduled for an open posterior thoracolumbar spinal fusion procedure
  1. * Allergy to TXA
  2. * Acquired disturbances of color vision
  3. * Refusal of blood products
  4. * Pre-op use of anticoagulant therapy within five days before surgery
  5. * History of arterial or venous thromboembolic disease (such as DVT, PE, CVA, TIA)
  6. * Pregnancy
  7. * Breastfeeding
  8. * Severe ischemic heart disease \[New York Heart Association Class III or IV\]
  9. * Previous myocardial infarction
  10. * Severe pulmonary disease
  11. * Renal impairment
  12. * Hepatic failure
  13. * Patients who decline to participate
  14. * Intolerance or sensitivity to Vitamin C

Contacts and Locations

Study Contact

Matthew Colman, MD
CONTACT
312-432-2468
an.research@rushortho.com

Principal Investigator

Bryce Basques, MD
PRINCIPAL_INVESTIGATOR
Rush University Medical Center

Study Locations (Sites)

Rush University Medical Center
Chicago, Illinois, 6060712
United States

Collaborators and Investigators

Sponsor: Rush University Medical Center

  • Bryce Basques, MD, PRINCIPAL_INVESTIGATOR, Rush University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-08-26
Study Completion Date2026-01-01

Study Record Updates

Study Start Date2019-08-26
Study Completion Date2026-01-01

Terms related to this study

Additional Relevant MeSH Terms

  • Open Posterior Thoracolumbar Spinal Fusion Procedure