Weighted Versus Uniform Dose of Tranexamic Acid in Patients Undergoing Primary, Knee Arthroplasty

Phase 2

Completed

Conditions: Osteoarthritis
Intraoperative Bleeding

Interventions: Drug: Females receiving a uniform dose of TA
Drug: Females Tranexamic Acid weighted dose
Drug: Males Weighted Dose TA
Drug: Tranexamic Acid standard dose

Registration Number: NCT01651806

Lead Sponsor: Rush University Medical Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 65

Inclusion Criteria

Patients must be male or female of any race
Ages 18-80 years old
Patients must be undergoing an elective, primary knee arthroplasty
Patients must be able to understand and willing to cooperate with study procedures
Patients must be able to provide written and verbal informed consent

Exclusion Criteria

Allergy or intolerance to the study materials
History of a venous thromboembolic event being treated with life-long anticoagulation
Patients with a known congenital thrombophilia
Patients who have had a venous thromboembolic event within the 12 months preceding surgery
History of any substance abuse or dependence within the last 6 months
Failure in collecting a required data point during study
Those patients not indicated for knee replacement surgery including, pregnant women, those not cleared medically for the procedure and patients without significant radiographic evidence of degenerative joint disease.
Patient using autologous blood transfusion

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Females receiving a uniform dose of TA	Females receiving a uniform dose of TA	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.
Weighted dose of TA in female patients	Females Tranexamic Acid weighted dose	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.
Tranexamic acid weighted dose male	Males Weighted Dose TA	Male patients randomized to the weighted dose of TA. Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss.
Uniform single dose TA male patient	Tranexamic Acid standard dose	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.

Primary Outcome Measures

Name	Time	Method
Primary Intra-operative Blood Loss	Intra-operative, an average of 3 hours	Record intra-operative blood loss through drain output
Document Incidences of DVT and Other Thromboembolic Events.	1 year	DVT = Deep Venous thrombosis Patients were assessed every 12 hours for development of pain within the lower extremity. Any reported muscle pain was evaluate with a bedside venous ultrasound by an ultrasound technician.

Secondary Outcome Measures