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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of oral tranexamic acid for individuals undergoing shoulder replacement surgery. Researchers aim to determine if this medication aids in recovery shortly after surgery. Participants will receive either tranexamic acid or a placebo (a pill with no active drug) to compare outcomes. Ideal candidates are those planning their first shoulder joint replacement and without a history of serious conditions like cancer or heart disease. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that tranexamic acid is likely to be safe for humans?

Research has shown that tranexamic acid, used in shoulder replacement surgery, is well-tolerated by patients. One study found that both the pill and injection forms of tranexamic acid are equally safe and effective, reducing blood loss during surgery and decreasing the need for blood transfusions.

Another study examined its use specifically in shoulder joint replacement and confirmed its safety, with no significant increase in side effects like blood clots or blockages in lung arteries. Tranexamic acid is commonly used in various joint surgeries and continues to demonstrate a strong safety record.

These findings suggest that tranexamic acid is generally safe for patients undergoing shoulder replacement surgery. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for managing blood loss during shoulder replacement surgery, which often involves intravenous tranexamic acid, this treatment uses an oral form. Researchers are excited about this approach because it offers a potentially easier and more comfortable way for patients to receive the medication, reducing the need for IV access. Additionally, oral administration could streamline the surgical process and improve patient satisfaction without compromising effectiveness.

What evidence suggests that oral tranexamic acid is effective for shoulder replacement surgery?

Studies have shown that tranexamic acid reduces blood loss in patients undergoing shoulder replacement surgery. Research indicates that this treatment decreases the need for blood transfusions post-surgery. Patients receiving tranexamic acid experienced less of a drop in hemoglobin levels, retaining more red blood cells. One study found that tranexamic acid also reduced blood loss in reverse total shoulder arthroplasty, a type of shoulder replacement. In this trial, participants will receive either oral tranexamic acid or an oral placebo to evaluate its effectiveness. Overall, tranexamic acid has consistently shown positive results in managing blood loss during shoulder surgeries. ^{1 4 5 6 7}

Who Is on the Research Team?

Walter Smith, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8224725/

Tranexamic Acid in Shoulder Arthroplasty. A ... The present review has shown that TXA administration in shoulder arthroplasty has effectively reduced blood loss, postoperative hemoglobin decline and need for ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0972978X24004501

Tranexamic acid use in rotator cuff repair: A systematic ... The findings of the present systematic review suggested TXA administration improves visual clarity during RCR use, but may not affect operative time, irrigation ...

3. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-024-08159-6

Tranexamic acid administration in total shoulder arthroplasty Primary outcomes were blood loss volume and allogenic blood transfusion rate. Secondary outcomes were drain out, postoperative change in ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02043132

Tranexamic Acid in Reverse Total Shoulder Arthroplasty The purpose of this study is to examine the efficacy of TXA in reducing overall blood loss and transfusion rates in patients undergoing reverse total shoulder ...

5. jsesinternational.org jsesinternational.org/article/S2666-6383(24)00084-7/fulltext

Tranexamic acid use in arthroscopic rotator cuff repair This study aimed to assess the efficacy of tranexamic acid (TXA) in arthroscopic rotator cuff repairs by evaluating all available randomized controlled trials ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1045452722000050

Oral and intravenous tranexamic acid are equivalent at ... The purpose of this study was to compare the efficacy and safety of oral versus intravenous TXA in shoulder arthroplasty. We hypothesized that oral and ...

7. journals.lww.com journals.lww.com/md-journal/fulltext/2017/06020/efficiency_and_safety_of_tranexamic_acid_in.29.aspx

Efficiency and safety of tranexamic acid in reducing blood... Secondary outcomes included duration of surgery, length of hospital stay, and postoperative adverse effects such as deep vein thrombosis (DVT) and pulmonary ...