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临床试验/NCT04630886
NCT04630886终止早期 1 期

Local Injection of Tranexamic Acid May Reduce Bleeding, Injection Pain, and Other Post-op Complications During Mohs Micrographic Surgery

Riley McLean1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2021年6月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
终止
发起方
入组人数
34
试验地点
1
主要终点
Postoperative Complications

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

The surgeon performing the Mohs surgery will be aware of which group the participant is in. The participant will be masked.

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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).

干预措施: Tranexamic acid injection (Drug)

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).

干预措施: Lidocaine Epinephrine (Drug)

Control

Active Comparator

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

干预措施: Lidocaine Epinephrine (Drug)

结局指标

主要结局

Postoperative Complications

时间窗: From day of surgery to 12 weeks post-operation

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.

次要结局

  • Hemostasis(during surgery)
  • Injection Pain(30 minutes post initial injection)

研究者

发起方
Riley McLean
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Riley McLean

Principle Investigator

University of Massachusetts, Worcester

研究点 (1)

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