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

Primary Purpose

Blood Loss, Anatomic Total Shoulder Arthroplasty, Reverse Total Shoulder Arthroplasty

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tranexamic Acid
Placebo
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Loss

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tranexamic Acid Group

Placebo Group

Arm Description

Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.

Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision

Outcomes

Primary Outcome Measures

Post-operative Blood Loss
Equated based on the patient's predicted blood volume and change in hemoglobin from the pre-operative level to the lowest post-operative level.

Secondary Outcome Measures

Number of Units Transfused
Units of pack red blood cells that the patients recieved
Number of Patients Transfused
Patients who received a post-op transfusion of pack red blood cells
Number of Participants With Deep Vein Thrombosis
Must be diagnosed via ultrasound duplex
Number of Participants With Pulmonary Embolism
Must be diagnosed via CT chest or V/Q lung scan
Number of Participants With Stroke
Must be diagnosed via CT scan or MRI

Full Information

First Posted
October 3, 2015
Last Updated
October 4, 2021
Sponsor
Rush University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02569658
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Anatomic Total Shoulder Arthroplasty, Reverse Total Shoulder Arthroplasty, Transfusion, Tranexamic Acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic Acid Group
Arm Type
Experimental
Arm Description
Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Post-operative Blood Loss
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.
Time Frame
Average of 3 days post-operatively
Secondary Outcome Measure Information:
Title
Number of Units Transfused
Description
Units of pack red blood cells that the patients recieved
Time Frame
Average of 3 days post-operatively
Title
Number of Patients Transfused
Description
Patients who received a post-op transfusion of pack red blood cells
Time Frame
Average of 3 days post-operatively
Title
Number of Participants With Deep Vein Thrombosis
Description
Must be diagnosed via ultrasound duplex
Time Frame
30 days post-operative
Title
Number of Participants With Pulmonary Embolism
Description
Must be diagnosed via CT chest or V/Q lung scan
Time Frame
30 days post-operative
Title
Number of Participants With Stroke
Description
Must be diagnosed via CT scan or MRI
Time Frame
30 days post-operative

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Cvetanovich, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24986694
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.
Results Reference
background
PubMed Identifier
23927910
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.
Results Reference
background
PubMed Identifier
24090984
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.
Results Reference
background
PubMed Identifier
24751531
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.
Results Reference
background
PubMed Identifier
22623147
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.
Results Reference
background
PubMed Identifier
23651507
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.
Results Reference
background
PubMed Identifier
24196467
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.
Results Reference
background
PubMed Identifier
24196466
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.
Results Reference
background
PubMed Identifier
23881695
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.
Results Reference
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Investigation of Intravenous Tranexamic Acid With Anatomic and Reverse Total Shoulder Arthroplasty

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