TXA in Spine Surgery

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    600
  • sponsor
    Rush University Medical Center
Updated on 27 January 2021

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 a different method of delivery like intravenous (IV) TXA reduces the post-operative reduction in hemoglobin, hematocrit, number of transfusions, and postoperative blood loss following open spine surgery.

Description

Open lumbar spine surgery is associated with the risk of moderate to significant blood loss. Because TXA has been shown to significantly reduce the need for blood products during total joint replacement, it is now the standard of care for these procedures at many institutions. Oral and IV TXA have been found to be similarly efficacious in total joint replacements, but oral TXA is cheaper and allows for ease of repeat dosing.

Although low preoperative hemoglobin is a risk factor for transfusion, no studies that have compared standard single-dose oral or IV TXA dosing to repeated oral dosing of TXA in patients undergoing open spine surgery. Therefore, the aim of the study is to determine whether or not repeated dosing of oral or a different method of delivery like intravenous (IV) TXA reduces the post-operative reduction in hemoglobin, hematocrit, number of transfusions, and postoperative blood loss following open spine surgery.

Details
Condition Postoperative Blood Loss Following Spine Surgery
Treatment Tranexamic Acid
Clinical Study IdentifierNCT04672213
SponsorRush University Medical Center
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Any patient older than 18 years old and 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
major comorbidities (such as severe ischemic heart disease [New York Heart Association Class III or IV], previous myocardial infarction, severe pulmonary disease, renal impairment, or hepatic failure)
patients who decline to participate
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