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Blood LossNCT02569658

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

A study testing Tranexamic Acid in people with Blood Loss and Anatomic Total Shoulder Arthroplasty, run by Rush University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Tranexamic Acid
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
110 participants
Where
1 siteUnited States
Study dates
Sep 2015to Apr 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Any patient scheduled for a primary anatomic or reverse TSA

Who cannot join

  • 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
Show all 10Show fewer
  • Renal impairment
  • Refusal of blood products
  • Any patient undergoing a revision TSA
  • Patients who decline to participate

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Rush University Medical Center

    Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: Investigation of the Blood Sparing Properties 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.

Read the 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.

Being tested
Tranexamic Acid, Placebo
Medical subject headings
Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02569658
Study groupRoleWhat they receive
Tranexamic Acid GroupExperimentalGroup will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.
Receives: Drug: Tranexamic Acid
Placebo GroupPlacebo comparatorGroup will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Average of 3 days post-operatively

Secondary outcomes (5)

  1. Number of Units Transfused

    Units of pack red blood cells that the patients recieved

    Measured: Average of 3 days post-operatively

  2. Number of Patients Transfused

    Patients who received a post-op transfusion of pack red blood cells

    Measured: Average of 3 days post-operatively

  3. Number of Participants With Deep Vein Thrombosis

    Must be diagnosed via ultrasound duplex

    Measured: 30 days post-operative

  4. Number of Participants With Pulmonary Embolism

    Must be diagnosed via CT chest or V/Q lung scan

    Measured: 30 days post-operative

  5. Number of Participants With Stroke

    Must be diagnosed via CT scan or MRI

    Measured: 30 days post-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionApr 2017
  4. Study completionApr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02569658
Sponsor's protocol ID
Rush TXA TSA
Status last verified
Oct 2021
First submitted
3 Oct 2015
Last updated
2 Nov 2021
Data monitoring committee
No

Publications

  • 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.

    PubMed 24986694

  • 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.

    PubMed 23927910

  • 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.

    PubMed 24090984

  • 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.

    PubMed 24751531

  • 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.

    PubMed 22623147

  • 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.

    PubMed 23651507

  • 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.

    PubMed 24196467

  • 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.

    PubMed 24196466

  • 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.

    PubMed 23881695

Questions about this trial

What is this clinical trial studying?

A study testing Tranexamic Acid in people with Blood Loss and Anatomic Total Shoulder Arthroplasty, run by Rush University Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-operative Blood Loss (time frame: Average of 3 days post-operatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02569658, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.

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