Weighted Versus Uniform Dose of Tranexamic Acid in Patients Undergoing Primary, Knee Arthroplasty
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|ClinicalTrials.gov Identifier: NCT01651806|
Recruitment Status : Completed
First Posted : July 27, 2012
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Intraoperative Bleeding||Drug: Tranexamic Acid standard dose Drug: Females Tranexamic Acid weighted dose Drug: Females receiving a uniform dose of TA Drug: Males Weighted Dose TA||Phase 2 Phase 3|
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).
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Weighted Versus Uniform Dose of Tranexamic Acid in Patients Undergoing Primary, Knee Arthroplasty, a Randomized-clinical Trial.|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
Active Comparator: 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.
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.
Other Name: Tranexamic Acid
Active Comparator: Weighted dose of TA in female patients
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.
Drug: Females Tranexamic Acid weighted dose
Weighted dose--20mg/kg of the drug will be given
Other Name: TA
Active Comparator: Tranexamic acid weighted dose male
Male patients randomized to the weighted dose of TA. Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss.
Drug: Males Weighted Dose TA
Weighted dose--20mg/kg of the drug will be given
Other Name: Transexamic Acid
Active Comparator: Uniform single dose TA male patient
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.
Drug: Tranexamic Acid standard dose
Uniform 1 gram dosing
Other Name: Male TA
No Intervention: Historical Cohort
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.
- Primary Intra-operative Blood Loss [ Time Frame: Intra-operative, an average of 3 hours ]Record intra-operative blood loss through drain output
- Document Incidences of DVT and Other Thromboembolic Events. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651806
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|Study Director:||Mark Belkin, BS||Rush University Medical Center|