Back to resultsThe Role of Tranexamic Acid in Reducing Post Operative Hand Edema After Hand and Wrist Surgery (THAW)
Primary Purpose
Hand Injuries and Disorders, Distal Radius Fracture, Dupuytren Contracture
Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Tranexamic acid
Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Hand Injuries and Disorders focused on measuring swelling, edema, distal radius fracture, dupuytren, Tranexamic Acid
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
Sites / Locations
- Lawson Health Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tranexamic Acid (TXA)
Standard of Care (SOC)
Arm 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
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
Outcomes
Primary Outcome Measures
Adherence to protocol
Assess number of patients who receive hand volume measurements at all designated time intervals. The outcome goal will be 90%
Treatment Completion Rate
Asses proportion of patients who correctly receive the intervention as per the protocol. The outcome goal will be 90%
Retention Rate
Proportion of participants to complete the study protocol and associated follow up. The outcome goal will be an 80% retention rate
Recruitment rate
Number of patients recruited to the study per month. The outcome goal will be 5 patients per month
Secondary Outcome Measures
Hand volume
Hand volume will be assessed using two validated methods; water displacement and figure of eight measurement.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04907812
Brief Title
The Role of Tranexamic Acid in Reducing Post Operative Hand Edema After Hand and Wrist Surgery
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ruby Grewal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Injuries and Disorders, Distal Radius Fracture, Dupuytren Contracture
Keywords
swelling, edema, distal radius fracture, dupuytren, Tranexamic Acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
A Prospective, Randomized Controlled, Double-Blinded Pilot Study
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tranexamic Acid (TXA)
Arm Type
Experimental
Arm 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
Arm Title
Standard of Care (SOC)
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
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
Primary Outcome Measure Information:
Title
Adherence to protocol
Description
Assess number of patients who receive hand volume measurements at all designated time intervals. The outcome goal will be 90%
Time Frame
12 weeks
Title
Treatment Completion Rate
Description
Asses proportion of patients who correctly receive the intervention as per the protocol. The outcome goal will be 90%
Time Frame
12 weeks
Title
Retention Rate
Description
Proportion of participants to complete the study protocol and associated follow up. The outcome goal will be an 80% retention rate
Time Frame
12 weeks
Title
Recruitment rate
Description
Number of patients recruited to the study per month. The outcome goal will be 5 patients per month
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Hand volume
Description
Hand volume will be assessed using two validated methods; water displacement and figure of eight measurement.
Time Frame
12 weeks
Title
Patient-reported pain scores
Description
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
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Lawson Health Research Institute
City
London
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
The Role of Tranexamic Acid in Reducing Post Operative Hand Edema After Hand and Wrist Surgery
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