The Role of Tranexamic Acid in Reducing Post Operative Hand Edema After Hand and Wrist Surgery (THAW)

Ruby Grewal

Status and phase: Unknown; Phase 4

Conditions: Dupuytren Contracture; Hand Injuries and Disorders; Distal Radius Fracture

Treatments: Procedure: Surgery; Drug: Tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04907812

116724 (Other Identifier)

Details and patient eligibility

About

Hand edema following hand surgery is a common yet devastating side effect that can lead to early stiffness, prolonged rehabilitation and diminished function. These factors can reduce a patient's quality of life; mounting to an overall delay in recovery, return to work and daily activities. Conventional edema therapy includes cryotherapy, external compression, active and passive exercises and various types of massage. However, there is little evidence to suggest these modalities are effective. Tranexamic acid (TXA) is an antifibrinolytic that has been used in surgical disciplines for decades to aid in reducing intraoperative blood loss and consequent transfusions. Recently, the use of TXA for curbing post-operative edema and ecchymosis has shown promising results, however, its use in hand surgery has not been studied.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients >18 years old undergoing distal radius fracture open reduction and internal fixation through a volar approach at St. Joseph's hospital in London, Ontario
• All patients >18 years old undergoing open fasciectomy for Dupuytren's disease at St. Joseph's hospital in London, Ontario

Exclusion criteria

• Revision surgery
• Distal radius fractures treated with additive or alternative approaches and fixation to the volar approach
• Known history of lymphedema or lymph node dissection on either upper extremity
• Known allergic reaction to TXA
• Cardiovascular problems (history of myocardial infraction, angina, and atrial fibrillation)
• Cerebrovascular conditions (history of previous stroke)
• Thromboembolic disorders (history of deep vein thrombosis [DVT] or pulmonary embolism [PE]), clotting disorders)
• Known seizure disorder
• Currently on dialysis
• Current pregnancy or breastfeeding
• Current use of hormone contraception
• Unable to read consent and patient surveys related to the study in English

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Tranexamic Acid (TXA)

Experimental group

Description:

Patients in the TXA arm will receive 1 gram dose of intravenous (IV) tranexamic acid mixed with 50cc 0.9% sodium chloride before their surgery and 1 gram dose of intravenous (IV) tranexamic acid mixed with 50cc 0.9% sodium chloride 3-6 hours after the first dose on the day of their surgery

Treatment:

Drug: Tranexamic acid

Procedure: Surgery

Standard of Care (SOC)

Placebo Comparator group

Description:

Patients in the (SOC) arm will receive 50cc of IV Placebo (standard intravenous normal saline fluid - 0.9% sodium chloride) before their surgery and 50cc of IV Placebo (standard intravenous normal saline fluid - 0.9% sodium chloride) 3-6 hours after the first dose on the day of their surgery

Treatment:

Procedure: Surgery