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

Conditions

• Open Posterior Thoracolumbar Spinal Fusion Procedure

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tranexamic Acid Injectable Product (1000 mg intravenous bolus) — DRUG
  Intravenous methods to decrease blood loss
• Vitamin C 250 MG Oral Tablet — DRUG
  Oral method of placebo
• Tranexamic Acid 650Mg Tablet — DRUG
  Oral method of treatment group

Study Details

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.

Key Dates

Start date

Aug 26, 2019

Status verified

Jan 2026

Primary completion

Dec 1, 2026

Completion

Jan 1, 2027

Study Design

Enrollment

604 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Placebo Comparator: Group 1 PLACEBO
• Experimental: Group 2 IV TXA
• Experimental: Group 3 Pre-Oral TXA
• Experimental: Group 4 Full Oral TXA

Primary Outcome Measure

Postoperative blood loss [ Time Frame: During hospital stay and at routine outpatient follow-up visit which occurs about 3 weeks after discharge and within 30 days of surgery ]

Central Contacts

• Matthew Colman, MD
  312-432-2468
  [email protected]

Locations (1)

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