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

NCT ID: NCT04630886

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-16
• Study Completion Date: 2024-01-16

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.

Detailed Description

The primary objective of this study is to evaluate the efficacy of subcutaneous infiltration of tranexamic acid (TXA) in the reduction of peri- and post-operative complications including bleeding, infections, flap and graft loss in anticoagulated patients undergoing Mohs micrographic surgery. A secondary objective is to evaluate the ability of TXA to increase the pH of lidocaine with epinephrine, and whether it causes less pain than the alternative during injection of local anesthetic.

TXA may serve as an effective local antifibrinolytic agent to decrease perioperative and postoperative bleeding while also causing less injection pain in patients undergoing Mohs surgery.

Background:

TXA is a well-established antifibrinolytic agent used in many surgical fields to effectively reduce post-operative bleeding. TXA is a synthetic lysine analogue that prevents the lysis of polymerized fibrin in blood clots. It has been used intravenously, orally, and subcutaneously to reduce bleeding during orthopedic procedures, to manage postpartum bleeding, and in trauma patients to control significant hemorrhage. It has also been used intravenously to reduce the need for blood transfusions in cardiac and liver transplantation.The safety of TXA has been verified in numerous publications across multiple medical specialties. Additionally, the pH of TXA ranges from 6-8, indicating that it may serve as an effective buffering agent and cause less pain with injection of anesthetic agents.

Many institutions have begun to use tranexamic acid to reduce postoperative bleeding. The medication is now readily available in the Pyxis of the investigators. The use of TXA within the wound bed and underlying undermined edges of flaps performed in patients who are anticoagulated is becoming the standard of care. Anecdotally, this has been quite successful in reducing post operative bruising and post operative bleeding requiring an emergency visit. In this protocol, the study arm involving the use of TXA and the study arm without the use of TXA are currently standard of care and are currently routinely used intraoperatively in clinical practice.

The investigators are performing this study to examine the efficacy of TXA as a safe, local antifibrinolytic agent in dermatologic surgeries and will analyze postoperative bleeding as well as other postoperative complications.

Conditions

Skin Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Tranexamic acid

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 Type: EXPERIMENTAL

Tranexamic acid injection

Intervention Type: DRUG

subcutaneous injection of 50mg/ml TXA

Lidocaine Epinephrine

Intervention Type: DRUG

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

Control

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

Group Type: ACTIVE_COMPARATOR

Lidocaine Epinephrine

Intervention Type: DRUG

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

Interventions

Tranexamic acid injection

subcutaneous injection of 50mg/ml TXA

Intervention Type: DRUG

Lidocaine Epinephrine

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riley McLean

OTHER

Sponsor Role: lead

Responsible Party

Riley McLean

Principle Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Riley McLean, MD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Worcester

Locations

University of Massachusetts Medical School

Worcester, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 30640775 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25116268 (View on PubMed)

Other Identifiers

H00019337

Identifier Type: -

Identifier Source: org_study_id