NCT01651806

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

Weighted Versus Uniform Dose of Tranexamic Acid in Patients Undergoing Primary, Knee Arthroplasty, a Randomized-clinical Trial.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Osteoarthritis
• Intraoperative Bleeding

Interventions

Type	Name	Description
DRUG	Tranexamic Acid standard dose	Uniform 1 gram dosing
DRUG	Females Tranexamic Acid weighted dose	Weighted dose--20mg/kg of the drug will be given
DRUG	Females receiving a uniform dose of TA	Patients will receive a uniform 1 gm dose of tranexamic acid prior to tourniquet release during a primary TKA.
DRUG	Males Weighted Dose TA	Weighted dose--20mg/kg of the drug will be given

Timeline

• Start date: 2012-05-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2012-07-27
• Last updated: 2017-12-13
• Results posted: 2017-12-13

Locations

1 site across 1 country: United States