60 Participants Needed

Oral Tranexamic Acid for Shoulder Replacement Surgery

WS
Overseen ByWalter Smith
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: University of Alabama at Birmingham
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking anticoagulants (blood thinners) other than aspirin.

What data supports the effectiveness of the drug Tranexamic Acid for shoulder replacement surgery?

Research shows that Tranexamic Acid can reduce blood loss and the need for blood transfusions during and after shoulder replacement surgery. It has been effective in similar surgeries, like knee and hip replacements, and studies indicate it helps decrease blood volume loss and changes in blood levels during shoulder surgeries.12345

Is oral tranexamic acid safe for humans?

Tranexamic acid has been used in various surgeries, including shoulder replacements, and is generally considered safe. Studies show it does not increase the risk of complications, even in patients with a history of blood clots.12367

How is the drug tranexamic acid unique for shoulder replacement surgery?

Tranexamic acid is unique for shoulder replacement surgery because it helps reduce blood loss during and after the procedure, which can decrease the need for blood transfusions. Unlike other treatments, it specifically targets the reduction of blood loss by preventing the breakdown of blood clots, making it particularly useful in surgeries where bleeding is a concern.12458

What is the purpose of this trial?

The purpose of this clinical trial is to evaluate the short-term clinical outcomes of patients undergoing total shoulder arthroplasty who receive an extended postoperative course of oral tranexamic acid

Research Team

WS

Walter Smith

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for patients who are scheduled to undergo total shoulder arthroplasty, which is a type of shoulder replacement surgery. Specific eligibility criteria have not been provided.

Exclusion Criteria

Patients allergic to TXA
Patients with current tobacco use
I have had blood clots in my veins.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an extended postoperative course of oral tranexamic acid following total shoulder arthroplasty

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Tranexamic Acid
Trial Overview The study aims to assess the effects of oral tranexamic acid on patients' recovery shortly after they've had total shoulder arthroplasty compared to a placebo.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: oral tranexamic acidExperimental Treatment1 Intervention
Group II: Oral PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Findings from Research

In a study of 71,174 shoulder arthroplasty patients, tranexamic acid (TXA) significantly reduced the need for blood transfusions without increasing the risk of complications, even in patients with a history of thrombotic events.
TXA use in patients with a history of thrombotic events was associated with a reduction in hospitalization costs, suggesting it is a safe and effective option for managing blood loss in these patients.
Administration of tranexamic acid during total shoulder arthroplasty is not associated with increased risk of complications in patients with a history of thrombotic events.Carbone, A., Poeran, J., Zubizarreta, N., et al.[2021]

References

Tranexamic acid decreases blood loss in total shoulder arthroplasty and reverse total shoulder arthroplasty. [2022]
Inconclusive evidence for the efficacy of tranexamic acid in reducing transfusions, postoperative infection or hematoma formation after primary shoulder arthroplasty: A meta-analysis with trial sequential analysis. [2022]
Tranexamic acid use is associated with lower transfusion rates in shoulder arthroplasty patients with preoperative anaemia. [2022]
Tranexamic Acid in Shoulder Arthroplasty: A Systematic Review and Meta-Analysis. [2021]
Tranexamic Acid for Shoulder Arthroplasty: A Systematic Review and Meta-Analysis. [2022]
Tranexamic acid in total shoulder arthroplasty and reverse shoulder arthroplasty: a systematic review and meta-analysis. [2022]
Administration of tranexamic acid during total shoulder arthroplasty is not associated with increased risk of complications in patients with a history of thrombotic events. [2021]
Tranexamic acid achieves less blood loss volume of in primary shoulder arthroplasty: a systematic review and meta-analysis of level I randomized controlled trials. [2023]
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