NCT01651806|CompletedPhase 2/3ResultsDMC
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Sponsor study identifier
interventional
65
1 country
1
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2015
Actual (reported)Study Completion
March 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
May 1, 2012
Actual (reported)July 27, 2012
Actual (reported)March 2015
Actual (reported)March 2015
Actual (reported)December 13, 2017
Actual (reported)Primary Intra-operative Blood Loss
Record intra-operative blood loss through drain output
Intra-operative, an average of 3 hours
Document Incidences of DVT and Other Thromboembolic Events.
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.
1 year
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.
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.
Uniform 1 gram dosing
Weighted dose--20mg/kg of the drug will be given
Rush University Medical Center
Chicago, Illinois, 60612, United States
Kagoma YK, Crowther MA, Douketis J, Bhandari M, Eikelboom J, Lim W. Use of antifibrinolytic therapy to reduce transfusion in patients undergoing orthopedic surgery: a systematic review of randomized trials. Thromb Res. 2009 Mar;123(5):687-96. doi: 10.1016/j.thromres.2008.09.015. Epub 2008 Nov 12.
Husted H, Blond L, Sonne-Holm S, Holm G, Jacobsen TW, Gebuhr P. Tranexamic acid reduces blood loss and blood transfusions in primary total hip arthroplasty: a prospective randomized double-blind study in 40 patients. Acta Orthop Scand. 2003 Dec;74(6):665-9. doi: 10.1080/00016470310018171.
Mark Belkin, BS
Rush University Medical Center
65 participants (actual enrollment reported by the registry).
First Submitted
May 1, 2012
First Posted
July 27, 2012
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Intra-articular Tranexamic Acid in the Reduction of Blood Transfusions in Primary Total Hip and Total Knee Arthroplasty
Male patients randomized to the weighted dose of TA. Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss.
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.
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.
Patients will receive a uniform 1 gm dose of tranexamic acid prior to tourniquet release during a primary TKA.
Weighted dose--20mg/kg of the drug will be given
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Ralley FE, Berta D, Binns V, Howard J, Naudie DD. One intraoperative dose of tranexamic Acid for patients having primary hip or knee arthroplasty. Clin Orthop Relat Res. 2010 Jul;468(7):1905-11. doi: 10.1007/s11999-009-1217-8. Epub 2010 Jan 9.
Primary Completion
March 2015
Actual (reported)Study Completion
March 2015
Actual (reported)Last Updated
December 13, 2017
Results First Posted
December 13, 2017
Record last verified: 2017-12
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Source: ClinicalTrials.gov.
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