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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02569658
Recruitment Status : Completed
First Posted : October 7, 2015
Results First Posted : May 24, 2017
Last Update Posted : May 24, 2017
Sponsor:
Information provided by (Responsible Party):
Yale Fillingham, Rush University Medical Center

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.

Condition or disease Intervention/treatment Phase
Blood Loss Anatomic Total Shoulder Arthroplasty Reverse Total Shoulder Arthroplasty Transfusion Tranexamic Acid Drug: Tranexamic Acid Drug: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigation of the Blood Sparing Properties of Intravenous Tranexamic Acid With Anatomic and Reverse Total Shoulder Arthroplasty
Study Start Date : September 2015
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tranexamic Acid Group
Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.
Drug: Tranexamic Acid
Placebo Comparator: Placebo Group
Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision
Drug: Placebo



Primary Outcome Measures :
  1. Post-operative Blood Loss [ Time Frame: Average of 3 days post-operatively ]
    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 :
  1. Number of Units Transfused [ Time Frame: Average of 3 days post-operatively ]
    Units of pack red blood cells that the patients recieved

  2. Number of Patients Transfused [ Time Frame: Average of 3 days post-operatively ]
    Patients who received a post-op transfusion of pack red blood cells

  3. Number of Participants With Deep Vein Thrombosis [ Time Frame: 30 days post-operative ]
    Must be diagnosed via ultrasound duplex

  4. Number of Participants With Pulmonary Embolism [ Time Frame: 30 days post-operative ]
    Must be diagnosed via CT chest or V/Q lung scan

  5. Number of Participants With Stroke [ Time Frame: 30 days post-operative ]
    Must be diagnosed via CT scan or MRI



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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): NCT02569658


Locations
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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
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Principal Investigator: Yale A Fillingham, MD Rush University Medical Center
Publications:

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Responsible Party: Yale Fillingham, Orthopaedic Surgery Resident, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02569658    
Other Study ID Numbers: Rush TXA TSA
First Posted: October 7, 2015    Key Record Dates
Results First Posted: May 24, 2017
Last Update Posted: May 24, 2017
Last Verified: April 2016
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants