Tranexamic Acid for Postoperative Complications

Overseen By Steven Krueger, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Riley McLean

Must be taking: Anticoagulants

Must not be taking: Retinoids

Disqualifiers: Hypercoaguable disorder, DVT, Pregnancy, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

34 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 it requires participants to be on blood-thinners. If you are taking systemic retinoids, you cannot participate.

What data supports the effectiveness of the drug tranexamic acid for reducing postoperative complications?

Research shows that tranexamic acid can significantly reduce blood loss during knee surgery, with one study noting a reduction of 340 mL in blood loss and fewer blood transfusions needed. This suggests it may help in managing blood loss in other surgeries as well. ^{1 2 3 4 5}

Is tranexamic acid generally safe for humans?

Tranexamic acid is generally safe for humans, but there have been serious safety concerns when it is mistakenly given in the wrong way, such as into the spine instead of as intended. This error can cause severe reactions like convulsions (seizures) and has a high risk of death, so hospitals are advised to store it carefully to prevent such mistakes. ^{1 6 7 8 9}

How does the drug tranexamic acid differ from other treatments for reducing postoperative complications?

Tranexamic acid is unique because it works by preventing the breakdown of blood clots, which helps reduce blood loss during and after surgery. It is administered as an injection, often before surgical procedures like knee arthroplasty, to minimize the need for blood transfusions and manage bleeding more effectively than some other treatments. ^{1 2 3 5 10}

What is the purpose of this trial?

This trial is testing whether injecting tranexamic acid (TXA) under the skin can reduce bleeding and pain during skin cancer surgery for patients on blood thinners. TXA helps by preventing blood clots from breaking down too quickly. The goal is to see if this method can lead to fewer complications after surgery. Tranexamic acid (TXA) has been used since the 1960s to safely control bleeding in various surgical and trauma settings.

Research Team

Riley McLean, MD

Principal Investigator

University of Massachusetts, Worcester

Eligibility Criteria

Inclusion Criteria

Must be scheduled for Mohs surgery at the University of Massachusetts Department of Dermatology

Must be on systemic anticoagulation therapy (indirect or direct anticoagulants or anti-platelet agents)

Exclusion Criteria

History of hypercoaguable disorder (e.g. Factor V Leiden Deficiency)

Systolic blood pressure greater than 200 on day of surgery

Unable to consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Mohs micrographic surgery with or without tranexamic acid (TXA) to evaluate its efficacy in reducing peri- and post-operative complications

1 day

1 visit (in-person)

Follow-up

Participants are monitored for postoperative complications, including infection, bleeding, and graft failure

12 weeks

Multiple visits (in-person and/or virtual) as needed

Treatment Details

Interventions

• Lidocaine Epinephrine
• Tranexamic acid injection

Participant Groups

Group I: Tranexamic acid Experimental Treatment 2 Interventions

The TXA group will receive 2% lidocaine with 1:100,000 epinephrine mixed 50/50 with 50mg/ml TXA (with 50% dilution, this will yield 1% lidocaine with 1:200,000 epi).

Group II: Control Active Control 1 Intervention

The control group will use the routine local anesthetic of buffered 1% lidocaine with 1:200,000 epinephrine.

Tranexamic acid injection is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Cyklokapron for:

• Heavy menstrual bleeding
• Bleeding due to trauma
• Bleeding during surgery
• Hereditary angioedema

Approved in United States as Lysteda for:

• Heavy menstrual bleeding
• Bleeding due to trauma
• Bleeding during surgery

Approved in Canada as Tranexamic Acid Injection for:

• Heavy menstrual bleeding
• Bleeding due to trauma
• Bleeding during surgery

Approved in Japan as Tranexamic Acid Injection for:

• Heavy menstrual bleeding
• Bleeding due to trauma
• Bleeding during surgery

Who Is Running the Clinical Trial?

Riley McLean

Lead Sponsor

Trials

1

Recruited

30+

Findings from Research

In a study of 179 total knee arthroplasties, the use of tranexamic acid before tourniquet release significantly reduced postoperative blood loss by an average of 340 mL compared to a control group.

Patients treated with tranexamic acid also experienced a reduction in blood transfusions, going from a median of 2 units in the control group to 0 units, with no significant increase in complications except for a higher number of postoperative hematomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does tranexamic acid reduce blood loss in knee arthroplasty? Benoni, G., Carlsson, A., Petersson, C., et al.[2022]

Intraoperative injection of tranexamic acid (TXA) during total knee arthroplasty (TKA) significantly reduced postoperative blood loss and the need for blood transfusions, as shown in a study of 100 patients.

The TXA group experienced lower drainage volumes and milder ecchymosis compared to the control group, indicating that TXA is both effective and safe for minimizing hemorrhage during TKA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety evaluation of intra-articular injection of tranexamic acid in total knee arthroplasty operation with temporarily drainage close. Wang, G., Wang, D., Wang, B., et al.[2020]

In a study of 88 patients undergoing total knee arthroplasty, the use of tranexamic acid significantly reduced postoperative blood loss and increased postoperative hemoglobin levels compared to the control group.

The use of tranexamic acid did not increase the risk of deep venous thrombosis (DVT), indicating it is a safe option for managing blood loss during TKA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of tranexamic acid in total knee arthroplasty]. Chen, X., Xie, S., Wang, K.[2018]

Tranexamic acid is effective in treating postpartum hemorrhage, but there have been increasing reports of serious errors where it was mistakenly administered intrathecally instead of local anesthetic, leading to severe neurotoxicity and a high mortality rate of 50%.

To prevent these catastrophic errors, it is crucial to implement safety measures such as storing tranexamic acid separately from anesthetics and raising awareness among healthcare providers, as current alerts from health organizations have not sufficiently mitigated the risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tranexamic acid at cesarean delivery: drug-error deaths. Moran, NF., Bishop, DG., Fawcus, S., et al.[2022]

Tranexamic acid is effective in treating postpartum hemorrhage, but there have been increasing reports of serious errors where it was mistakenly administered intrathecally instead of local anesthetics, leading to severe neurotoxicity and a high mortality rate of 50%.

To prevent these catastrophic errors, it is crucial to implement safety measures such as storing tranexamic acid separately from anesthetics and raising awareness among healthcare providers, as current alerts from health organizations have not sufficiently mitigated the risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tranexamic acid at cesarean delivery: drug-error deaths. Moran, NF., Bishop, DG., Fawcus, S., et al.[2023]

Tranexamic acid is effective in treating postpartum hemorrhage, but there have been increasing reports of serious errors where it was mistakenly administered intrathecally instead of local anesthetic, leading to severe neurotoxicity and a high mortality rate of 50%.

To prevent these catastrophic errors, it is crucial to implement safety measures such as storing tranexamic acid separately from anesthetics and raising awareness among healthcare providers, as current safety alerts have not been sufficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tranexamic acid at cesarean delivery: drug-error deaths. Moran, NF., Bishop, DG., Fawcus, S., et al.[2023]

Tranexamic acid is effective in treating postpartum hemorrhage, but there have been increasing cases of it being mistakenly administered intrathecally instead of local anesthetics, leading to severe neurotoxicity and a high mortality rate of 50%.

To prevent these tragic errors, it is crucial to implement safety measures such as storing tranexamic acid separately from anesthetics and raising awareness among healthcare providers, as current alerts from health organizations have not been sufficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tranexamic acid at cesarean delivery: Drug-error deaths. Moran, NF., Bishop, DG., Fawcus, S., et al.[2022]

References

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

Does tranexamic acid reduce blood loss in knee arthroplasty? [2022]

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

Efficacy and safety evaluation of intra-articular injection of tranexamic acid in total knee arthroplasty operation with temporarily drainage close. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Tranexamic acid (Cyklokapron) reduces perioperative blood loss associated with total knee arthroplasty. [2022]

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

Peri-Articular Injection of Tranexamic Acid Reduce Blood Loss and Transfusion Requirement During Total Knee Arthroplasty: A Meta-analysis. [2022]

5. China pubmed.ncbi.nlm.nih.gov

[Effectiveness of tranexamic acid in total knee arthroplasty]. [2018]

6. Ireland pubmed.ncbi.nlm.nih.gov

Tranexamic acid at cesarean delivery: drug-error deaths. [2022]

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

Tranexamic acid at cesarean delivery: drug-error deaths. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Tranexamic acid at cesarean delivery: drug-error deaths. [2023]

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

Tranexamic acid at cesarean delivery: Drug-error deaths. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Diffusion of tranexamic acid to the joint. [2022]