Tranexamic Acid for Postoperative Hemorrhage

(TXA Trial)

Overseen By Jennifer Mutch, MDCM, FRCSC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Mary's Research Center, Canada

Disqualifiers: Thromboembolic disease, Active malignancy, Renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

210 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether extra doses of tranexamic acid (TXA), a medicine that reduces bleeding, can aid recovery after hip or knee replacement surgery. The researchers aim to determine if additional TXA reduces visible bleeding, improves movement, and lessens pain post-surgery. The study compares three groups: one receiving standard care, another with extra TXA doses at two times, and a third with more frequent doses. Participants must undergo a primary hip or knee replacement at St-Mary's Hospital and be comfortable using a specific app for tracking recovery. As an unphased trial, this study provides an opportunity to contribute to understanding how TXA can enhance recovery after surgery.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that tranexamic acid (TXA) is generally safe for most people. Since the 1960s, it has reduced blood loss during surgeries, such as those for injuries or bone operations. Studies have found that TXA effectively reduces bleeding without causing significant risks.

For the pill form of TXA, research indicates it is as safe and effective as the version given through a needle (IV). Taking TXA by mouth works as well as receiving it through an injection. The FDA has approved oral TXA for treating heavy menstrual bleeding, highlighting its safety for regular use.

When given by IV, TXA decreases blood loss and reduces the need for blood transfusions during surgery. Studies confirm that using TXA in this way does not increase the risk of major side effects.

Overall, both oral and IV TXA have a strong history of safety and effectiveness. Most people tolerate it well, making it a reliable choice for reducing bleeding during surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard of care, which typically involves intravenous administration of tranexamic acid (TXA) during surgery, this approach explores the use of oral TXA post-operatively. Researchers are excited about these treatments because oral administration could offer more convenient and sustained dosing, potentially improving patient comfort and compliance. Additionally, by spreading out the doses over a 24-hour period, it may provide more effective control of bleeding after surgery compared to the traditional method. This could represent a significant advancement in managing postoperative hemorrhage, especially in terms of ease of use and overall effectiveness.

What is the effectiveness track record for tranexamic acid in reducing postoperative hemorrhage?

Research has shown that tranexamic acid (TXA) helps reduce blood loss during surgeries. In this trial, participants will receive different forms of TXA as part of separate treatment arms. Both the pill and IV forms of TXA can lessen bleeding during and after surgery. For instance, one study found no major difference in blood loss or the need for blood transfusions between the two forms, indicating both work well. TXA has been safely used in many surgeries, including hip and knee replacements. Its proven effectiveness and safety have made TXA a common choice in medical guidelines worldwide. ^{1 2 3 6 7}

Who Is on the Research Team?

Jennifer Mutch, MDCM, FRCSC

Principal Investigator

St. Mary's Hospital Centre

Are You a Good Fit for This Trial?

This trial is for adults undergoing their first total knee (TKA) or hip arthroplasty (THA) at St-Mary's Hospital. It aims to include a broad range of patients who are scheduled for these surgeries.

Inclusion Criteria

I am an adult scheduled for a primary knee or hip replacement at St-Mary's Hospital.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Treatment

Participants undergo total hip or knee arthroplasty and receive standard TXA dosing

1 day

In-patient surgery

Post-operative Treatment

Participants receive additional oral doses of TXA at 0, 8, 16, and 24 hours post-operatively

1 day

Follow-up

Participants are monitored for safety, effectiveness, and recovery progress, including pain, mobility, and bleeding assessments

4-6 weeks

Multiple visits for assessments

What Are the Treatments Tested in This Trial?

Interventions

• Tranexamic Acid

Trial Overview The study tests Tranexamic acid (TXA), an agent that reduces blood loss, in different doses post-surgery. The focus is on its effects on bleeding, pain levels, mobility, and joint function after TKA and THA procedures.

How Is the Trial Designed?

Group I: 3) Standard + 1G oral TXA given at 0, 8, 16 and 24 hours post-operatively Active Control 1 Intervention

Standard + 1G oral TXA given at 0, 8, 16 and 24 hours post-operatively

Group II: 1)Standard care: 1G TXA IV Active Control 1 Intervention

1 gm TA IV given prior to incision and 1G TXA IV during cementation or closure

Group III: 2) Standard + 1G oral TXA - 0 and 8 hours post-operatively Active Control 1 Intervention

Standard + 1G oral TXA given at 0 and 8 hours post-operatively

Who Is Running the Clinical Trial?

St. Mary's Research Center, Canada

Lead Sponsor

Trials

11

Recruited

1,800+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40978753/

a systematic review and meta-analysis Intravenous TXA reduced intraoperative and postoperative bleeding volume (including 2, 4, 6, and 24-h postoperative bleeding). It also decreased ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666548424000957

64. Comparison of the effects of topical and intravenous ... Total postoperative blood loss was significantly lower in the TXA (t) group than in the TXA (iv) and control groups (350.8±132.6 vs 566.4±178.8 vs 704.4±225.9, ...

3. eor.bioscientifica.com eor.bioscientifica.com/view/journals/eor/10/10/EOR-2025-0027.xml

Evidence on oral tranexamic acid versus intravenous ... The results showed no significant difference between oral and intravenous TXA in terms of Hb decrease and transfusion rates. Similarly, there ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK532909/

Tranexamic Acid - StatPearls - NCBI Bookshelf The study data suggest that TXA improves survival when administered within 3 hours of the injury in patients with significant hemorrhage.[4][5] ...

5. journals.lww.com journals.lww.com/md-journal/fulltext/2023/05190/the_efficacy_and_safety_of_intravenous.7.aspx

The efficacy and safety of intravenous administration of... This current study suggested that intravenous TXA significantly reduced total volume of postoperative bleeding in both adult and pediatric patients undergoing ...

6. nejm.org nejm.org/doi/full/10.1056/NEJMoa2201171

Tranexamic Acid in Patients Undergoing Noncardiac Surgery Tranexamic acid reduces the incidence and severity of bleeding in patients undergoing cesarean section or cardiac surgery.

7. thrombosisjournal.biomedcentral.com thrombosisjournal.biomedcentral.com/articles/10.1186/s12959-021-00303-9

Tranexamic acid for the prevention and treatment of bleeding ... Both a single preoperative intravenous dose of 10–20 mg/kg TXA or 1 % TXA irrigation appeared effective (Table 1) [37,38,39, 121]. In addition ...