Tranexamic Acid in Revision Total Joint Arthroplasty

Acute Blood Loss Anemia Clinical Trial

Official title:

Tranexamic Acid in Revision Total Joint Arthroplasty: A Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02877381
• Other study ID #: 15063007
• Status: Completed
• Phase: Phase 4
• Start date: April 2016
• Est. completion date: August 1, 2019

Study information

• Verified date: April 2021
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the optimal dosing regimen and route of administration of tranexamic acid (TXA) [single dose intravenous (IV), double dose intravenous, intravenous + topical, and oral repeated dosing] to minimize post-operative blood loss and transfusion requirements following revision total knee arthroplasty (RTKA).

Description:

Study Design: Prospective randomized control study

Scientific Background/Intro: Total hip or knee arthroplasty is associated with the risk of moderate to significant blood loss. Approximately one-third of patients undergoing total joint replacement surgery require one to three units of blood postoperatively. Tranexamic acid is a synthetic antifibrinolytic agent that has been successfully used orally, intravenously, and topically to control bleeding after total joint replacement. The use of TXA has been shown to significantly reduce the need for blood products during total joint replacement.1-3

Many studies have explored the use of various TXA regimens following primary TKA. Tanaka et al. demonstrated both that pre-operative administration of TXA was superior to intra-operative administration and that a double dose regimen is superior to a single dose regimen.4 Maniar et al. further supported the idea that pre-operative TXA administration is superior, and the addition of higher doses of TXA improved efficacy without an increase in thromboembolic complications.5 More recently, Lin et al. demonstrated that combining a pre-operative IV dose of TXA with an intra-articular dose after arthrotomy closure was superior to an intra-articular dose alone.6 Also, in an unpublished randomized control trial that we recently completed, we found oral TXA to provide equivalent blood control at a lower cost than IV TXA.

It is well known that revision joint arthroplasty cases are more complex than primary joint replacements. Revision total knee arthroplasty is associated with a greater risk of blood loss and increased transfusion rates compared to primary TKA.7 Despite the vast body of literature investigating TXA following primary TKA, only three retrospective studies have been published on the use of TXA after revision TKA.8-10 All three studies have shown that IV TXA decreased both the rate of transfusions and the amount of blood transfused when compared to controls.8-10

Although the TXA formulations used in primary TKA have been shown to be effective in the retrospective studies, the amount of blood loss and risk of transfusion still remains significantly higher than during primary TKA. By performing the first randomized control trial on the use of TXA following revision TKA, we believe it will help change practice patterns by providing evidence that the same TXA formulations used in primary TKA are inadequate for revision TKA. Additionally, we will be exploring new combinations of TXA administration to answer some questions brought up by previous studies in regards to the optimal TXA regimen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients scheduled for revision THA or TKA defined as femoral component exchange, acetabulum/tibial component exchange, both component exchange, explant of both components and placement of antibiotic cement spacer, or a second stage re-implantation procedure.

Exclusion Criteria:

• Patients scheduled for a head and liner/poly exchange, 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 (DVT), Pulmonary Embolism (PE), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA)), pregnancy, breastfeeding, or major co-morbidities (myocardial infarction or stent placement within one year, severe pulmonary disease, renal impairment, or hepatic failure).

Related Conditions & MeSH terms

• Acute Blood Loss Anemia
• Hemorrhage
• Revision Total Hip Arthroplasty
• Revision Total Knee Arthroplasty

Intervention

Procedure:
• Revision Total Knee Arthroplasty (TKA)
Femoral component exchange, tibial component exchange, both component exchange, explant of both components and placement of antibiotic cement spacer, or a second stage re-implantation procedure. Given the variability in blood loss between types of revision TKA, randomization will be done to ensure equivalent numbers of each type of revision TKA between the treatment groups.
• Revision Total Hip Arthroplasty (THA)
Femoral component exchange, acetabulum component exchange, both component exchange, explant of both components and placement of antibiotic cement spacer, or a second stage re-implantation procedure. Given the variability in blood loss between types of revision THA, randomization will be done to ensure equivalent numbers of each type of revision THA between the treatment groups.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois
United States	New York University Medical Center	New York	New York
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative reduction in Hemoglobin	Pre-operative hemoglobin minus the lowest post-operative hemoglobin prior to any transfusion	Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Primary	Post-operative reduction in Hematocrit	Pre-operative hematocrit minus the lowest post-operative hematocrit prior to any transfusion	Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Primary	Calculated blood loss	Based on predicted blood volume and hemoglobin balance	Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Primary	Number of units transfused	per patient	Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Primary	Number of Patients Transfused		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	Deep Vein Thrombosis, Pulmonary Embolus, Cerebrovascular accident or Transient ischemic attack		Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Secondary	Return to the OR within 30 days; Re-admission within 30 days; Periprosthetic fracture within 30 days		Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Secondary	Superficial infection or Deep infection, defined as Synovial White Blood Cell (WBC) count > 4200 WBC/ml or Synovial WBC > 3000 WBC/ml & C-Reactive Protein (CRP) > 10 mg/dl & Erythrocyte Sedimentation Rate (ESR) > 30 mm/hr ;		Post-operative and before discharge from hospital (inpatient), < 30 days from surgery