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Completed

NCT Number: NCT02569658

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

Placebo

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 7, 2015
Registry last updated
Nov 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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