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

Phase 4

• Conditions: Distal Radius Fracture; Dupuytren Contracture; Hand Injuries and Disorders
• Interventions: Drug: Tranexamic acid; Procedure: Surgery

• Registration Number: NCT04907812
• Lead Sponsor: Ruby Grewal

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-06
• Status Verified: 2021-05
• Study First Submitted QC: 2021-05-25
• Last Update Submitted: 2021-05-25
• Study Start: 2021-06-01
• Study First Posted: 2021-06-01
• Last Update Posted: 2021-06-01
• Primary Completion: 2021-12-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic Acid (TXA)	Surgery	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
Standard of Care (SOC)	Surgery	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
Tranexamic Acid (TXA)	Tranexamic acid	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

Primary Outcome Measures

Name	Time	Method
Treatment Completion Rate	12 weeks	Asses proportion of patients who correctly receive the intervention as per the protocol. The outcome goal will be 90%
Retention Rate	12 weeks	Proportion of participants to complete the study protocol and associated follow up. The outcome goal will be an 80% retention rate
Recruitment rate	12 weeks	Number of patients recruited to the study per month. The outcome goal will be 5 patients per month
Adherence to protocol	12 weeks	Assess number of patients who receive hand volume measurements at all designated time intervals. The outcome goal will be 90%

Secondary Outcome Measures

Name	Time	Method
Patient-reported pain scores	12 weeks	Patient Reported Wrist and Hand Evaluation (PRWHE). The PRWHE allows patients to rate their levels of hand and wrist pain and disability. It is rated on a 0-100 scale. A higher score in the scale denotes a worse outcome
Hand volume	12 weeks	Hand volume will be assessed using two validated methods; water displacement and figure of eight measurement.

Trial Locations

Locations (1)

Lawson Health Research Institute; 🇨🇦 London, Ontario, Canada