Status:
RECRUITING
Single Versus Multi-Dose Oral and Intravenous Tranexamic Acid Patients at High Risk for Blood Transfusion After Spine Surgery
Lead Sponsor:
Rush University Medical Center
Conditions:
Open Posterior Thoracolumbar Spinal Fusion Procedure
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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 ...
Detailed Description
Background/Scientific review: 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 produc...
Eligibility Criteria
Inclusion
- Any patient older than 18 years old
- Scheduled for an open posterior thoracolumbar spinal fusion procedure
Exclusion
- 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
Key Trial Info
Start Date :
August 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
604 Patients enrolled
Trial Details
Trial ID
NCT03849443
Start Date
August 26 2019
End Date
January 1 2027
Last Update
January 8 2026
Active Locations (1)
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1
Rush University Medical Center
Chicago, Illinois, United States, 6060712