drugset / Trial / NCT02569658
Investigation of Intravenous Tranexamic Acid With Anatomic and Reverse Total Shoulder Arthroplasty
RandomizedParallel-groupQuadruple-blindTreatment
Summary
To compare intravenous Tranexamic Acid (TXA) versus normal saline placebo to determine whether or not TXA administration reduces blood loss, decrease in hemoglobin, and rate of transfusions following anatomic and reverse total shoulder arthroplasty (TSA) surgeries.
Timeline
- Start
- 2015-09
- Primary completion
- 2017-04
- Completion
- 2017-04
Publications
- Background Saltzman BM, Chalmers PN, Gupta AK, Romeo AA, Nicholson GP. Complication rates comparing primary with revision reverse total shoulder arthroplasty. J Shoulder Elbow Surg. 2014 Nov;23(11):1647-54. doi: 10.1016/j.jse.2014.04.015. Epub 2014 Jun 28.
- Background Chalmers PN, Gupta AK, Rahman Z, Bruce B, Romeo AA, Nicholson GP. Predictors of early complications of total shoulder arthroplasty. J Arthroplasty. 2014 Apr;29(4):856-60. doi: 10.1016/j.arth.2013.07.002. Epub 2013 Aug 6.
- Background Gupta AK, Chalmers PN, Rahman Z, Bruce B, Harris JD, McCormick F, Abrams GD, Nicholson GP. Reverse total shoulder arthroplasty in patients of varying body mass index. J Shoulder Elbow Surg. 2014 Jan;23(1):35-42. doi: 10.1016/j.jse.2013.07.043. Epub 2013 Sep 30.
- Background Shields E, Iannuzzi JC, Thorsness R, Noyes K, Voloshin I. Perioperative complications after hemiarthroplasty and total shoulder arthroplasty are equivalent. J Shoulder Elbow Surg. 2014 Oct;23(10):1449-53. doi: 10.1016/j.jse.2014.01.052. Epub 2014 Apr 18.
- Background Yang ZG, Chen WP, Wu LD. Effectiveness and safety of tranexamic acid in reducing blood loss in total knee arthroplasty: a meta-analysis. J Bone Joint Surg Am. 2012 Jul 3;94(13):1153-9. doi: 10.2106/JBJS.K.00873.
- Background Gandhi R, Evans HM, Mahomed SR, Mahomed NN. Tranexamic acid and the reduction of blood loss in total knee and hip arthroplasty: a meta-analysis. BMC Res Notes. 2013 May 7;6:184. doi: 10.1186/1756-0500-6-184.
- Background Alshryda S, Mason J, Sarda P, Nargol A, Cooke N, Ahmad H, Tang S, Logishetty R, Vaghela M, McPartlin L, Hungin AP. Topical (intra-articular) tranexamic acid reduces blood loss and transfusion rates following total hip replacement: a randomized controlled trial (TRANX-H). J Bone Joint Surg Am. 2013 Nov 6;95(21):1969-74. doi: 10.2106/JBJS.L.00908.
- Background Alshryda S, Mason J, Vaghela M, Sarda P, Nargol A, Maheswaran S, Tulloch C, Anand S, Logishetty R, Stothart B, Hungin AP. Topical (intra-articular) tranexamic acid reduces blood loss and transfusion rates following total knee replacement: a randomized controlled trial (TRANX-K). J Bone Joint Surg Am. 2013 Nov 6;95(21):1961-8. doi: 10.2106/JBJS.L.00907.
- Background Ker K, Beecher D, Roberts I. Topical application of tranexamic acid for the reduction of bleeding. Cochrane Database Syst Rev. 2013 Jul 23;2013(7):CD010562. doi: 10.1002/14651858.CD010562.pub2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tranexamic Acid | Small molecule | 1 g | Intravenous |
Indications
No indication recorded.