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

Distal Radius Fracture Clinical Trial

— THAW  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04907812
• Other study ID #: 116724
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 1, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: May 2021
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contracture
• Distal Radius Fracture
• Dupuytren Contracture
• Hand Injuries
• Hand Injuries and Disorders
• Radius Fractures

Intervention

Drug:
• Tranexamic acid
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

Procedure:
• Surgery
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

Locations

Country	Name	City	State
Canada	Lawson Health Research Institute	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ruby Grewal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Treatment Completion Rate	Asses proportion of patients who correctly receive the intervention as per the protocol. The outcome goal will be 90%	12 weeks
Primary	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
Primary	Recruitment rate	Number of patients recruited to the study per month. The outcome goal will be 5 patients per month	12 weeks
Secondary	Hand volume	Hand volume will be assessed using two validated methods; water displacement and figure of eight measurement.	12 weeks
Secondary	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