Chicago, Illinois 60612


Purpose:

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.


Study summary:

Anatomic and reverse total shoulder arthroplasty (TSA) is associated with the risk of moderate to significant blood loss that can lead to transfusions. Average estimated blood loss has been reported in the range of 354 to 361 mL intraoperatively, not accounting for additional postoperative blood loss postoperatively in surgical drains. Transfusion rates have been reported to range from 2.4% to 9.5% in recent studies, with rates over 30% for revision cases. Tranexamic acid (TXA) is a synthetic antifibrinolytic agent that is an established method of reducing blood loss and transfusion requirement for patients undergoing total hip and knee arthroplasty. TXA can be administered intravenously, topically (intraarticularly), or orally, with most available literature addressing intravenous and topical administration. Systematic reviews and meta-analyses of the total hip and knee arthroplasty literature demonstrate approximately a 30% decrease in blood loss and 50% decrease in transfusion rate with topical or intravenous administration of TXA compared to placebo. Moreover, the literature demonstrates no increased rate of thromboembolic or other complications associated with TXA administration for hip and knee arthroplasty. Despite proven efficacy in the hip and knee arthroplasty literature, there have been no studies analyzing the ability of TXA to reduce blood loss and transfusion rate following TSA. Purpose of the study is 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. With the hypothesis that intravenous TXA will reduce blood loss following TSA.


Criteria:

Inclusion Criteria: - Any patient scheduled for a primary anatomic or reverse TSA Exclusion Criteria: - Allergy to TXA - Acquired disturbances of color vision - Pre-op use of anticoagulant therapy within five days before surgery - History of arterial or venous thromboembolic disease; such as DVT, PE, CVA, TIA - Pregnancy or breastfeeding - Recent MI (within 6 months of surgery) or any placement of stent regardless of time since placement - Renal impairment - Refusal of blood products - Any patient undergoing a revision TSA - Patients who decline to participate


Study is Available At:


Original ID:

Rush TXA TSA


NCT ID:

NCT02569658


Secondary ID:


Study Acronym:


Brief Title:

Investigation of Intravenous Tranexamic Acid With Anatomic and Reverse Total Shoulder Arthroplasty


Official Title:

Investigation of the Blood Sparing Properties of Intravenous Tranexamic Acid With Anatomic and Reverse Total Shoulder Arthroplasty


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Rush University Medical Center


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

300


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Yale A Fillingham, MD
Principal Investigator
Rush University Medical Center
Primary Contact:Yale A Fillingham, MD
312-942-6000 ext. 3384
312-942-6000
yale_fillingham@rush.edu

Study Dates

Start Date:September 2015
Completion Date:June 2017
Completion Type:Anticipated
Primary Completion Date:March 2017
Primary Completion Type:Anticipated
Verification Date:April 2016
Last Changed Date:April 21, 2016
First Received Date:October 3, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Stroke
Time Frame:30 days post-operative
Safety Issues:True
Description:Must be diagnosed via CT scan or MRI
Outcome Type:Secondary Outcome
Measure:Pulmonary Embolism
Time Frame:30 days post-operative
Safety Issues:True
Description:Must be diagnosed via CT chest or V/Q lung scan
Outcome Type:Secondary Outcome
Measure:Deep Vein Thrombosis
Time Frame:30 days post-operative
Safety Issues:True
Description:Must be diagnosed via ultrasound duplex
Outcome Type:Secondary Outcome
Measure:Number of patients transfused
Time Frame:Average of 3 days post-operatively
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Number of units transfused
Time Frame:Average of 3 days post-operatively
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Post-operative reduction in hematocrit
Time Frame:Average of 3 days post-operatively
Safety Issues:False
Description:Measured as the pre-operative hematocrit minus the lowest post-operative hematocrit or the hematocrit prior to transfusion.
Outcome Type:Secondary Outcome
Measure:Post-operative reduction in hemoglobin
Time Frame:Average of 3 days post-operatively
Safety Issues:False
Description:Measured as the pre-operative hemoglobin minus the lowest post-operative hemoglobin or the hemoglobin prior to transfusion.
Outcome Type:Primary Outcome
Measure:Post-operative blood loss
Time Frame:Average of 3 days post-operatively
Safety Issues:False
Description:Equated based on the patient's predicted blood volume and change in hemoglobin from the pre-operative level to the lowest post-operative level.

Study Interventions

Intervention Type:Drug
Name:Tranexamic Acid
Arm Name:Tranexamic Acid Group
Intervention Type:Drug
Name:Placebo
Arm Name:Placebo Group

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo Group
Description:Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision
Study Arm Type:Experimental
Arm Name:Tranexamic Acid Group
Description:Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Rush University Medical Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Ker K, Beecher D, Roberts I. Topical application of tranexamic acid for the reduction of bleeding. Cochrane Database Syst Rev. 2013 Jul 23;7:CD010562. doi: 10.1002/14651858.CD010562.pub2. Review.
PMID:23881695
Reference Type:Reference
Citation: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.
PMID:24196466
Reference Type:Reference
Citation: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.
PMID:24196467
Reference Type:Reference
Citation: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.
PMID:23651507
Reference Type:Reference
Citation: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.
PMID:22623147
Reference Type:Reference
Citation: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.
PMID:24751531
Reference Type:Reference
Citation: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.
PMID:24090984
Reference Type:Reference
Citation: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.
PMID:23927910
Reference Type:Reference
Citation: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.
PMID:24986694

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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