Clinical trial NCT01651806
Conditions: Osteoarthritis Intraoperative Bleeding
Keywords: Blood loss transfusion rates complications
Sponsor: Rush University Medical Center
Start date: 2012-05-01; Completion date: 2015-03-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Hypotheses: Primary - A weighted dose of 20 mg/kg of tranexamic acid will be more efficacious than a single uniform dose of 1 gram in primary total knee arthroplasty (TKA) cases. This includes having a greater impact on decreasing blood loss without increasing the occurrence of adverse thromboembolic events in patients undergoing primary, elective total knee arthroplasty.

Secondary - TA will decrease blood loss more effectively in women than in men undergoing this procedure.

Detailed description:
Overall Study Design

Study design and control methods:

This study is designed as a prospective, randomized, double-blinded controlled clinical trial to compare the effect of a single uniform 1 g dose of TA and a single weighted 20 mg/kg dose of tranexamic acid (TA).

Treatment group:

The subjects will be randomly assigned to the uniform dose group or weighted dose group at the time of the surgery via the opening of a randomly selected closed envelope. The patient and the independent reviewer will be blinded as to the dose of TA utilized during the surgery. This information will be linked to a confidential database for later review by the principal investigator.

Treatment allocation:

All eligible patients (i.e., meeting inclusion criteria and no exclusion criteria) will be treated and observed per the research protocol. All patients will maintain the right to refuse participation and receive a specific treatment of the study if desired.

Trial Population

Target population:

The target sample size is 60 patients of each of the uniform and weighted dose groups (120 total). There will be one actively enrolling surgeon (Dr. Brett Levine). The goal is to enroll a total of 120 subjects experiencing joint pain that warrants a TKA. The specific diagnosis for the joint pain will not direct the subjects' assignment or eligibility at the time of surgery. All 120 patients will be enrolled from the office of the primary investigator (Dr. Brett Levine). All indications for TKA will be included unless one of the exclusion criteria is met.

Results from randomized patients will be compared to a historical control arm that did not receive TA in their treatment.

Arms: arm 1: Women receiving a single dose of 1 gram of TA--includes all women that will get 1 gram dose of the TA during surgery. Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. arm 2: Female patients receiving a weighted dose of TA. Will include all women that will get a weighted dose of the TA during surgery. Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. arm 3: Male patients randomized to the weighted dose of TA. Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. arm 4: Male patients receiving a single dose (1gram) of TA during TKA. Includes all men that will get 1 gram dose of the TA during surgery. Postop outcomes wil be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups. arm 5: 25 patients with no TA use in their surgical history.

A control group was established from a historical cohort of primary TKAs performed by the senior author (BL), none of which received TA. The most relevant Pubmed ID would be 24997651.
Interventions: intervention 1: Tranexamic Acid standard dose intervention 2: Females Tranexamic Acid weighted dose intervention 3: Females receiving a uniform dose of TA intervention 4: Males Weighted Dose TA
Intervention descriptions: intervention 1: Uniform 1 gram dosing intervention 2: Weighted dose--20mg/kg of the drug will be given intervention 3: Patients will receive a uniform 1 gm dose of tranexamic acid prior to tourniquet release during a primary TKA. intervention 4: Weighted dose--20mg/kg of the drug will be given

Protocol documents: