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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02926651
• Other study ID #: 16060110
• Status: Withdrawn
• Phase: Phase 4
• Start date: October 2016
• Est. completion date: July 2017

Study information

• Verified date: October 2021
• 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 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.

Description:

Total joint arthroplasty 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 at many institutions. Oral and intravenous TXA are equivalent, 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 TXA dosing to risk stratified dosing of TXA. 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 regimen.

At the pre-operative clinic appointment and before the day of surgery, the study staff will assess the potential subject's eligibility. Once eligibility is established, the potential subject will be approached regarding their participation in this clinical trial. The investigators will provide 48 hours before the date of surgery to allot for questions and consideration of the Informed Consent document. Once all patient questions have been answered, patients willing to be in the study will sign the Informed Consent. Patients will be randomized, via standard randomization tables that provide a 1:1 distribution of subjects between the two groups through blocked randomization, no later than the morning of surgery to either of the two treatment groups: Conventional Oral TXA Group or Multi-Dose Oral TXA Group.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Arthritis
• Total Hip Arthroplasty
• Total Knee Arthroplasty

Intervention

Drug:
• Conventional Oral TXA (Tranexamic Acid)
Three 650mg tablets of oral TXA 2 hours prior to incision with three 250mg tablets of ascorbic acid (oral TXA placebo) given 6 hours postoperatively and a final 750mg ascorbic acid dose given the morning of postoperative day 1.
• Multi-Dose Oral TXA (Tranexamic Acid)
Three 650mg tablets of oral TXA 2 hours prior to incision with a second 1950mg oral TXA dose given 6 hours postoperatively and a final 1950mg oral TXA dose given the morning of postoperative day 1.

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	Number of patients transfused	Number of patients transfused per each of the 4 treatment arms	Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Primary	Number of units Packed Red Blood Cells (PRBCs) transfused	Number of units Packed Red Blood Cells (PRBCs) transfused per each of the 4 treatment arms	Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Secondary	Post-operative reduction in hemoglobin and hematocrit		Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Secondary	Calculated blood loss	Based on predicted blood volume and hemoglobin balance	Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
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	Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Secondary	Complications	Deep Vein Thrombosis, Pulmonary Embolus, return to the Operating Room within 30 days, superficial or deep infection, and cerebrovascular accident, transient ischemic attack or Myocardial Infarction	Post-operative and before discharge from hospital (inpatient), < 30 days from surgery