Use of Tranexamic Acid in Reduction of Post-Op Complications in Mohs Micrographic Surgery

NCT04630886 | Terminated Early Phase 1 FDA Drug

• 1 other identifier: H00019337
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the use of locally injected tranexamic acid (TXA) under the skin during Mohs micrographic surgery for removal of skin cancers in patients on anticoagulation. TXA may be helpful in reducing bleeding and pain during surgery, and may also lead to fewer post-operative complications following surgery such as graft loss, specifically in patients on blood-thinners.

Conditions

Skin Neoplasms

Outcome Measures

Primary Outcomes (1)

• Postoperative Complications

  Primary outcome measures will be the number of postoperative complications, including infection, bleeding (necessitating phone calls to providers or additional clinic visits), hematoma formation, and flap or graft failure.

  From day of surgery to 12 weeks post-operation

Secondary Outcomes (2)

• Hemostasis

  during surgery

• Injection Pain

  30 minutes post initial injection

Study Arms (2)

Tranexamic acid

EXPERIMENTAL

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).

Drug: Tranexamic acid injection; Drug: Lidocaine Epinephrine

Control

ACTIVE COMPARATOR

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

Drug: Lidocaine Epinephrine

Interventions

Tranexamic acid injection DRUG

subcutaneous injection of 50mg/ml TXA

Tranexamic acid

Lidocaine Epinephrine DRUG

subcutaneous injection of 1% lidocaine mixed with 1:200,000 epinephrine

Control; Tranexamic acid

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be on systemic anticoagulation therapy (indirect or direct anticoagulants or anti-platelet agents)
• Must be scheduled for Mohs surgery at the University of Massachusetts Department of Dermatology

You may not qualify if:

• History of hypercoaguable disorder (e.g. Factor V Leiden Deficiency)
• History of deep vein thrombosis or pulmonary embolism
• Systolic blood pressure greater than 200 on day of surgery
• Known allergy to TXA
• Currently taking systemic retinoids
• Unable to consent
• Pregnant women
• Prisoners

Sponsors & Collaborators

• Riley McLean: lead

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01605, United States

Location

Related Publications (2)

• Zilinsky I, Barazani TB, Visentin D, Ahuja K, Martinowitz U, Haik J. Subcutaneous Injection of Tranexamic Acid to Reduce Bleeding During Dermatologic Surgery: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial. Dermatol Surg. 2019 Jun;45(6):759-767. doi: 10.1097/DSS.0000000000001786.

  PMID: 30640775 BACKGROUND

• Poeran J, Rasul R, Suzuki S, Danninger T, Mazumdar M, Opperer M, Boettner F, Memtsoudis SG. Tranexamic acid use and postoperative outcomes in patients undergoing total hip or knee arthroplasty in the United States: retrospective analysis of effectiveness and safety. BMJ. 2014 Aug 12;349:g4829. doi: 10.1136/bmj.g4829.

  PMID: 25116268 BACKGROUND

MeSH Terms

Conditions

Skin Neoplasms

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Riley McLean, MD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The surgeon performing the Mohs surgery will be aware of which group the participant is in. The participant will be masked.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Once a participant has provided informed consent to participate in the study, he/she will be randomly assigned to either the TXA experimental group or the control group. A randomized list will be created prior to the start of the study with the help of a biostatistician. The provider will be aware of which study arm the participant is in, however the participant will be blinded.

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 16, 2020
• Study Start: June 16, 2021
• Primary Completion: January 16, 2024
• Study Completion: January 16, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)