TXA in Spine Surgery

Postoperative Blood Loss Following Spine Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04672213
• Other study ID #: 17081704
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2017
• Est. completion date: December 1, 2023

Study information

• Verified date: December 2020
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Postoperative Blood Loss Following Spine Surgery
• Postoperative Hemorrhage

Intervention

Drug:
• Tranexamic acid
Intravenous or oral tranexamic pre- and/or postoperatively

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transfusion	Number of subjects transfused blood products and units of blood transfused.	30 days postoperatively
Primary	Hemoglobin/Hematocrit	Postoperative reduction in hemoglobin and hematocrit	30 days postoperatively
Secondary	Cost comparison	Cost differences resulted from differences in the blood transfusion rate, length of hospital stay, and management of complications as well as from the cost of the TXA itself.	30 days
Secondary	Postoperative Complications	Deep vein thrombosis (DVT), Pulmonary embolism (PE), return to the operating room within 30 days, superficial or deep infection, cerebrovascular accident, transient ischemic attack, or myocardial infarction	30 days