Hand Injuries and DisordersPhase 4THAWNCT04907812
The Role of Tranexamic Acid in Reducing Post Operative Hand Edema After Hand and Wrist Surgery
A Phase 4 study testing Tranexamic acid and Surgery in people with Hand Injuries and Disorders and Distal Radius Fracture, run by Ruby Grewal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Injuries and Disorders, Distal Radius Fracture, Dupuytren Contracture
- What is being tested?
- Tranexamic acid and Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2021to 1 Jun 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Tranexamic acid, Surgery
- Keywords
- swelling, edema, distal radius fracture, dupuytren, Tranexamic Acid
- Medical subject headings
- Hand Injuries, Disease, Wrist Fractures, Dupuytren Contracture, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
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
SurgeryProcedure or 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to protocol
Assess number of patients who receive hand volume measurements at all designated time intervals. The outcome goal will be 90%
Measured: 12 weeks
Treatment Completion Rate
Asses proportion of patients who correctly receive the intervention as per the protocol. The outcome goal will be 90%
Measured: 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
Measured: 12 weeks
Recruitment rate
Number of patients recruited to the study per month. The outcome goal will be 5 patients per month
Measured: 12 weeks
Secondary outcomes (2)
Hand volume
Hand volume will be assessed using two validated methods; water displacement and figure of eight measurement.
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand Injuries and DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Prospective, Randomized Controlled, Double-Blinded Pilot Study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruby Grewal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ruby Grewal, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907812
- Sponsor's protocol ID
- 116724
- Acronym
- THAW
- Status last verified
- May 2021
- First submitted
- 6 Apr 2021
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04907812
- Acronym / sponsor ID
- THAW / 116724
- Keywords
- swelling, edema, distal radius fracture, dupuytren, Tranexamic Acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ruby GrewalUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A Prospective, Randomized Controlled, Double-Blinded Pilot Study
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid (TXA) | Experimental | Drug: Tranexamic acid, Procedure: SurgeryPatients 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 |
| Standard of Care (SOC) | Placebo comparator | Procedure: SurgeryPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic 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 | Drug | Tranexamic Acid (TXA) |
| SurgeryThis 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 | Procedure or surgery | Standard of Care (SOC), Tranexamic Acid (TXA) |
Primary outcome
Adherence to protocol
Time frame: 12 weeks
Assess number of patients who receive hand volume measurements at all designated time intervals. The outcome goal will be 90%
Treatment Completion Rate
Time frame: 12 weeks
Asses proportion of patients who correctly receive the intervention as per the protocol. The outcome goal will be 90%
Retention Rate
Time frame: 12 weeks
Proportion of participants to complete the study protocol and associated follow up. The outcome goal will be an 80% retention rate
Recruitment rate
Time frame: 12 weeks
Number of patients recruited to the study per month. The outcome goal will be 5 patients per month
2 secondary outcomes
Hand volume
Time frame: 12 weeks
Patient-reported pain scores
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic acid and Surgery in people with Hand Injuries and Disorders and Distal Radius Fracture, run by Ruby Grewal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to protocol (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021.