Oral Tranexamic Acid for Shoulder Replacement Surgery

Overseen By Walter Smith

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Alabama at Birmingham

Must not be taking: Anticoagulants

Disqualifiers: Cancer, Stroke, Heart disease, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

60 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

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. ^{1 2 4 5 8}

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

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.

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

Group I: oral tranexamic acid Experimental Treatment 1 Intervention

Group II: Oral Placebo Placebo Group 1 Intervention

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

1. United States pubmed.ncbi.nlm.nih.gov

Tranexamic acid decreases blood loss in total shoulder arthroplasty and reverse total shoulder arthroplasty. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

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]

3. United States pubmed.ncbi.nlm.nih.gov

Tranexamic acid use is associated with lower transfusion rates in shoulder arthroplasty patients with preoperative anaemia. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Tranexamic Acid in Shoulder Arthroplasty: A Systematic Review and Meta-Analysis. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Tranexamic Acid for Shoulder Arthroplasty: A Systematic Review and Meta-Analysis. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Tranexamic acid in total shoulder arthroplasty and reverse shoulder arthroplasty: a systematic review and meta-analysis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

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]

8. Netherlands pubmed.ncbi.nlm.nih.gov

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]