A Phase 4 interventional study of Revision Total Knee Arthroplasty (TKA) and Revision Total Hip Arthroplasty (THA) in Revision Total Knee Arthroplasty, Revision Total Hip Arthroplasty and Acute Blood Loss Anemia, sponsored by Rush University Medical Center. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-22.
Sponsored by Rush University Medical Center · Phase 4, Interventional, and Prevention
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).
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TXA with an intra-articular dose after arthrotomy closure was superior to an intra-articular dose alone.6 Also, in an unpublished randomized control trial that we recently completed, we found oral TXA to provide equivalent blood control at a lower cost than IV TXA.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.
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Exclusion Criteria:
• 1 gram IV TXA administered at time of prepping and draping
Procedure: Revision Total Knee Arthroplasty (TKA) · Procedure: Revision Total Hip Arthroplasty (THA)
* 1 gram IV TXA administered at time of prepping and draping * 1 gram IV TXA administered prior to tourniquet deflation
Procedure: Revision Total Knee Arthroplasty (TKA) · Procedure: Revision Total Hip Arthroplasty (THA)
* 1 gram IV TXA administered at time of prepping and draping * 1 gram topical TXA injected intra-articular following closure of the arthrotomy
Procedure: Revision Total Knee Arthroplasty (TKA) · Procedure: Revision Total Hip Arthroplasty (THA)
• Three 650 mg tablets of TXA administered two hours prior surgery with a second dose given 6 hours postoperatively and a final dose given the morning of postoperative day 1
Procedure: Revision Total Knee Arthroplasty (TKA) · Procedure: Revision Total Hip Arthroplasty (THA)
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.
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.
Post-operative reduction in Hemoglobin
Pre-operative hemoglobin minus the lowest post-operative hemoglobin prior to any transfusion
Time frame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Post-operative reduction in Hematocrit
Pre-operative hematocrit minus the lowest post-operative hematocrit prior to any transfusion
Time frame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Calculated blood loss
Based on predicted blood volume and hemoglobin balance
Time frame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Number of units transfused
per patient
Time frame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Number of Patients Transfused
Time frame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
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
Time frame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Deep Vein Thrombosis, Pulmonary Embolus, Cerebrovascular accident or Transient ischemic attack
Time frame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Return to the OR within 30 days; Re-admission within 30 days; Periprosthetic fracture within 30 days
Time frame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
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 ;
Time frame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Plan to share: Undecided
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