Clinical trial NCT02877381: Tranexamic Acid in Revision Total Joint Arthroplasty
Official title: Tranexamic Acid in Revision Total Joint Arthroplasty: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Revision Total Knee Arthroplasty
Revision Total Hip Arthroplasty
Acute Blood Loss Anemia
Keywords: Tranexamic Acid
Blood Transfusion
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
First posted: 2016-08-24
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

Detailed 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TXA with an intra-articular dose after arthrotomy closure was superior to an intra-articular dose alone.6 Also, in an unpublished randomized control trial that we recently completed, we found oral TXA to provide equivalent blood control at a lower cost than IV TXA.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.

Eligibility criteria: 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).

Primary outcomes:
measure: Post-operative reduction in Hemoglobin
timeFrame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
measure: Post-operative reduction in Hematocrit
timeFrame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
measure: Calculated blood loss
timeFrame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
measure: Number of units transfused
timeFrame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
measure: Number of Patients Transfused
timeFrame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Secondary outcomes:
measure: Cost-comparison
timeFrame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
measure: Deep Vein Thrombosis, Pulmonary Embolus, Cerebrovascular accident or Transient ischemic attack
timeFrame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
measure: Return to the OR within 30 days; Re-admission within 30 days; Periprosthetic fracture within 30 days
timeFrame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
measure: 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 ;
timeFrame: Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: New York University Medical Center
state: New York
Study officials:
affiliation: Rush University Medical Center
name: Craig J Della Valle, MD
role: PRINCIPAL_INVESTIGATOR
References: