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

Study Overview
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Brief Summary
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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.

Official Title
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The Role of Tranexamic Acid in Reducing Post Operative Hand Edema After Hand and Wrist Surgery (THAW): A Prospective, Randomized Controlled, Double-Blinded Pilot Study

Conditions
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Hand Injuries and Disorders, Distal Radius Fracture, Dupuytren Contracture

Intervention / Treatment
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* Drug: Tranexamic acid
* Procedure: Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Prospective, Randomized Controlled, Double-Blinded Pilot Study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic Acid (TXA)<br>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 | Drug: Tranexamic acid<br>* Patients will receive 1 gram dose of intravenous (IV) tranexamic acid mixed with 50cc 0.9% sodium chloride before your surgery and 1 gram dose of intravenous (IV) tranexamic acid mixed with 50cc 0.9% sodium chloride 3-6 hours after your first dose on the day of your surgery<br>Procedure: Surgery<br>* This will include regional anaesthesia, tourniquet inflation to 250mmHg and perioperative antibiotics. At the conclusion of the procedure hemostasis will be achieved followed by standard closure technique. There will be three separate surgical groups that will undergo the outlined study protocol: 1) Distal radius fractures will be treated with open reduction from a volar approach only technique 2) Mild dupuytren's: a. Low: i. MCP joints <50 contracture ii. PIP joints <40 contracture b. 1-2 fingers involved 3) Severe dupuytren's a. High: i. MCP joints >50 degree contracture ii. PIP Joints >40 degrees contracture b. >2 fingers involved<br>|
| Placebo Comparator: Standard of Care (SOC)<br>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 | Procedure: Surgery<br>* This will include regional anaesthesia, tourniquet inflation to 250mmHg and perioperative antibiotics. At the conclusion of the procedure hemostasis will be achieved followed by standard closure technique. There will be three separate surgical groups that will undergo the outlined study protocol: 1) Distal radius fractures will be treated with open reduction from a volar approach only technique 2) Mild dupuytren's: a. Low: i. MCP joints <50 contracture ii. PIP joints <40 contracture b. 1-2 fingers involved 3) Severe dupuytren's a. High: i. MCP joints >50 degree contracture ii. PIP Joints >40 degrees contracture b. >2 fingers involved<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hand volume | Hand volume will be assessed using two validated methods; water displacement and figure of eight measurement. | 12 weeks | 
| Patient-reported pain scores | 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 | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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swelling, distal radius fracture, dupuytren, Tranexamic Acid, edema