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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether injecting tranexamic acid (TXA) during Mohs surgery for skin cancer can reduce bleeding, pain, and other complications in patients on blood thinners. Mohs surgery precisely removes skin cancer while preserving as much healthy tissue as possible. Participants will receive either a TXA injection with their anesthetic or the standard anesthetic alone. This trial is ideal for those taking blood-thinning medication and scheduled for Mohs surgery at the University of Massachusetts Department of Dermatology. As an Early Phase 1 trial, the research focuses on understanding how TXA works in people, offering participants a chance to contribute to groundbreaking treatment insights.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that tranexamic acid is generally safe with a low risk of side effects. It often helps prevent bleeding in certain situations, and most people tolerate it well. Common side effects may include issues with the kidneys, heart, or breathing, though these are uncommon. Allergic reactions can occur but are rare. The long history of its use and approval for other purposes suggests it is usually safe for people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using tranexamic acid (TXA) for postoperative complications because it offers a fresh approach to managing surgical bleeding. Unlike the standard use of local anesthetics like lidocaine with epinephrine, TXA is an antifibrinolytic agent that works by preventing the breakdown of blood clots. This mechanism can potentially reduce bleeding and the need for transfusions more effectively than current options. By combining TXA with a local anesthetic, the treatment could enhance safety and recovery post-surgery, offering a new way to tackle bleeding complications.

What evidence suggests that tranexamic acid injection might be an effective treatment for reducing postoperative complications in patients undergoing Mohs surgery?

Research has shown that tranexamic acid (TXA), which participants in this trial may receive, helps reduce bleeding during surgeries. Studies have found that TXA significantly lowers blood loss and the need for transfusions without increasing the risk of complications like blood clots. In general surgeries, TXA also reduces bleeding around the time of surgery. Additionally, TXA decreases minor bleeding under the skin after surgery. These findings suggest that TXA might help manage bleeding and other issues during and after skin cancer surgeries, especially for those on blood-thinning medications. ^{6 7 8 9 10}

Who Is on the Research Team?

Riley McLean, MD

Principal Investigator

University of Massachusetts, Worcester

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Lidocaine Epinephrine
• Tranexamic acid injection

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

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Impact of Tranexamic Acid on Bleeding Outcomes and ...

Conclusions: TXA significantly reduces postoperative drain output and minor hematomas in facelift surgery without increasing major complications ...

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Safety and Efficacy of Tranexamic Acid in General Surgery

In this study, TXA significantly reduced the risk of perioperative bleeding without increasing cardiovascular risk in patients undergoing general surgery ...

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bmj.com/content/349/bmj.g4829

Tranexamic acid use and postoperative outcomes in ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S2059775424000543

Systematic Review Tranexamic acid reduces perioperative ...

This current review demonstrated that administration of TXA led to a reduction in blood loss and hemoglobin loss without an increased risk of the development ...

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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.

6.

ncbi.nlm.nih.gov

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

Tranexamic Acid - StatPearls - NCBI Bookshelf

Tranexamic acid has a low adverse effect profile and is generally considered safe for administration in most instances.

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go.drugbank.com

go.drugbank.com/drugs/DB00302

Tranexamic acid: Uses, Interactions, Mechanism of Action

Tranexamic acid is an antifibrinolytic used to reduce or prevent hemorrhagic episodes, especially in the context of hyperfibrinolytic disorders.

8.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2020/022430s009lbl.pdf

LYSTEDA® (tranexamic acid) tablets, for oral use

Adverse Reactions in Long-term Studies. Long-term safety of LYSTEDA was studied in two open-label studies. In one study, subjects with physician-diagnosed heavy ...

9.

medsafe.govt.nz

medsafe.govt.nz/profs/datasheet/t/Tranexamicacidinj.pdf

TRANEXAMIC ACID

The commonly reported (≥ 1% to < 10%) complications in association with tranexamic acid were renal; cardiac; respiratory, thoracic and mediastinal disorders.

10.

webmd.com

webmd.com/drugs/2/drug-32677-1331/tranexamic-acid-oral/tranexamic-acid-650-milligram-tablet-oral/details

Tranexamic acid (Cyklokapron, Lysteda) - Uses, Side ...

Tranexamic acid may cause allergic reactions, which can be serious. Stop taking tranexamic acid and get help right away if you have any of the ...