The Role of Tranexamic Acid in Reducing Post Operative Hand Edema After Hand and Wrist Surgery

NCT04907812 | Unknown Phase 4

• 1 other identifier: 116724
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand Injuries and Disorders; Distal Radius Fracture; Dupuytren Contracture

Keywords

swelling; edema; distal radius fracture; dupuytren; Tranexamic Acid

Outcome Measures

Primary Outcomes (4)

• Adherence to protocol

  Assess number of patients who receive hand volume measurements at all designated time intervals. The outcome goal will be 90%

  12 weeks

• Treatment Completion Rate

  Asses proportion of patients who correctly receive the intervention as per the protocol. The outcome goal will be 90%

  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

  12 weeks

• Recruitment rate

  Number of patients recruited to the study per month. The outcome goal will be 5 patients per month

  12 weeks

Secondary Outcomes (2)

• Hand volume

  12 weeks

• Patient-reported pain scores

  12 weeks

Study Arms (2)

Tranexamic Acid (TXA)

EXPERIMENTAL

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

Standard of Care (SOC)

PLACEBO COMPARATOR

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

Interventions

Tranexamic acid DRUG

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

Tranexamic Acid (TXA)

Surgery PROCEDURE

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

Standard of Care (SOC); Tranexamic Acid (TXA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruby Grewal: lead

Study Sites (1)

Lawson Health Research Institute

London, Ontario, Canada

Location

MeSH Terms

Conditions

Hand Injuries; Disease; Wrist Fractures; Dupuytren Contracture; Edema

Interventions

Tranexamic Acid; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wrist Injuries; Arm Injuries; Fractures, Bone; Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Contracture; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-director of the clinical research lab within the Roth | McFarlane Hand and Upper Limb Center (HULC)

Model Details: A Prospective, Randomized Controlled, Double-Blinded Pilot Study

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: June 1, 2021
• Study Start: June 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2022
• Last Updated: June 1, 2021

Record last verified: 2021-05

Locations

CA (1)