Tranexamic Acid in Revision Total Joint Arthroplasty

Rush

Status and phase: Completed; Phase 4

Conditions: Revision Total Knee Arthroplasty; Acute Blood Loss Anemia; Revision Total Hip Arthroplasty

Treatments: Procedure: Revision Total Knee Arthroplasty (TKA); Procedure: Revision Total Hip Arthroplasty (THA)

Study type: Interventional

Funder types: Other

Identifiers

NCT02877381

15063007

Details and patient eligibility

About

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).

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TXA with an intra-articular dose after arthrotomy closure was superior to an intra-articular dose alone.6 Also, in an unpublished randomized control trial that we recently completed, we found oral TXA to provide equivalent blood control at a lower cost than IV TXA.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

Enrollment: 175 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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175 participants in 4 patient groups

Single IV Dose

Active Comparator group

Description:

• 1 gram IV TXA administered at time of prepping and draping

Treatment:

Procedure: Revision Total Hip Arthroplasty (THA)

Procedure: Revision Total Knee Arthroplasty (TKA)

Double Dose IV

Active Comparator group

Description:

* 1 gram IV TXA administered at time of prepping and draping * 1 gram IV TXA administered prior to tourniquet deflation

Treatment:

Procedure: Revision Total Hip Arthroplasty (THA)

Procedure: Revision Total Knee Arthroplasty (TKA)

IV + Topical

Active Comparator group

Description:

* 1 gram IV TXA administered at time of prepping and draping * 1 gram topical TXA injected intra-articular following closure of the arthrotomy

Treatment:

Procedure: Revision Total Hip Arthroplasty (THA)

Procedure: Revision Total Knee Arthroplasty (TKA)

Repeated Oral Dose

Active Comparator group

Description:

• 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

Treatment:

Procedure: Revision Total Hip Arthroplasty (THA)

Procedure: Revision Total Knee Arthroplasty (TKA)