Single Versus Multi-Dose Oral Tranexamic Acid in Patients at High Risk for Blood Transfusion After Total Joint Arthroplasty

• Status: Withdrawn
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

As tranexamic acid (TXA) becomes more prevalent, all patients are receiving the same dose regardless of their pre-operative risk of transfusion. Therefore the aim of the study is to determine whether or not repeated dosing of oral TXA reduces the post-operative reduction in hemoglobin, hematocrit, number of transfusions, and post-operative blood loss following primary TKA and THA surgeries in patients with low pre-operative hematocrit and high risk for transfusion. The investigators hypothesize that a multi-dose TXA regimen will significantly minimize post-operative blood loss and transfusion requirements compared to the use of a single dose regime.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rush University Medical Center
• Treatments: Ascorbic Acid; Tranexamic Acid

Criteria

Inclusion Criteria:

• older than 18 years

• scheduled for a primary cemented TKA or cementless THA

• preoperative hematocrit less than 36%

Exclusion Criteria:

• Known allergy to TXA

• acquired disturbances of color vision

• refusal of blood products

• pre-operative use of anticoagulant therapy within five days before surgery

• a history of arterial or venous thrombotic disease (including a history of Deep Vein Thrombosis, Pulmonary Embolus, Cerebrovascular accident or Transient ischemic attack)

• pregnancy, breastfeeding

• major co-morbidities (myocardial infarction or stent placement within one year, severe pulmonary disease, renal impairment, or hepatic failure)

• undergoing a revision TKA, revision THA, hip resurfacing, or Unicompartmental Knee Arthroplasty

• younger than 18 years old

• decline to participate