Trials / Unknown
UnknownNCT04907812
The Role of Tranexamic Acid in Reducing Post Operative Hand Edema After Hand and Wrist Surgery
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
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Ruby Grewal · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2021-06-01
- Primary completion
- 2021-12-01
- Completion
- 2022-06-01
- First posted
- 2021-06-01
- Last updated
- 2021-06-01
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT04907812. Inclusion in this directory is not an endorsement.