Clinical trial NCT04907812: The Role of Tranexamic Acid in Reducing Post Operative Hand Edema After Hand and Wrist Surgery
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hand Injuries and Disorders
Distal Radius Fracture
Dupuytren Contracture
Keywords: swelling
edema
distal radius fracture
dupuytren
Tranexamic Acid
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Prospective, Randomized Controlled, Double-Blinded Pilot Study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Adherence to protocol
timeFrame: 12 weeks
measure: Treatment Completion Rate
timeFrame: 12 weeks
measure: Retention Rate
timeFrame: 12 weeks
measure: Recruitment rate
timeFrame: 12 weeks
Secondary outcomes:
measure: Hand volume
timeFrame: 12 weeks
measure: Patient-reported pain scores
timeFrame: 12 weeks
Other outcomes:
Locations:
city: London
country: Canada
facility: Lawson Health Research Institute
state: Ontario
Study officials:
References: