A Phase 4 interventional study of Tranexamic acid and Surgery in Hand Injuries and Disorders, Distal Radius Fracture and Dupuytren Contracture, sponsored by Ruby Grewal. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-01.
Sponsored by Ruby Grewal · Phase 4, Interventional, and Treatment
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.
76 studies on the registry are indexed under Dupuytren Contracture; 16 are open to participants now.
This study's planned enrollment of 50 is below the median of 72 across 55 interventional studies indexed under Dupuytren Contracture.
Browse Dupuytren Contracture studies →This is the only study on the registry with Ruby Grewal as lead sponsor.
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Exclusion Criteria:
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
Drug: Tranexamic acid · Procedure: 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
Procedure: Surgery
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
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
Adherence to protocol
Assess number of patients who receive hand volume measurements at all designated time intervals. The outcome goal will be 90%
Time frame: 12 weeks
Treatment Completion Rate
Asses proportion of patients who correctly receive the intervention as per the protocol. The outcome goal will be 90%
Time frame: 12 weeks
Retention Rate
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
Recruitment rate
Number of patients recruited to the study per month. The outcome goal will be 5 patients per month
Time frame: 12 weeks
Hand volume
Hand volume will be assessed using two validated methods; water displacement and figure of eight measurement.
Time frame: 12 weeks
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
Time frame: 12 weeks
This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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