Clinical Trials Directory

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

TypeNameDescription
DRUGTranexamic acidPatients 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
PROCEDURESurgeryThis 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.