The Use of Tranexamic Acid in Decreasing Wound Complication in Total Ankle Replacement. A Pilot Randomized Controlled Trial (TXA in TAR)
Patients who undergo total ankle replacement surgery can sometimes develop problems with wound healing after their operation. These complications may include delayed healing, wound opening, or infection, which can lead to additional clinic visits, further surgery, and longer recovery times.
Tranexamic acid (TXA) is a medication that has been used safely for many years in many types of surgery to reduce bleeding. Some studies suggest that it may also improve wound healing after foot and ankle surgery by reducing bleeding and swelling around the surgical site. However, there is not enough high-quality evidence to know whether TXA truly improves outcomes for patients undergoing total ankle replacement.
This study is a pilot clinical trial designed to determine whether a larger study can be successfully carried out. Approximately 40 patients undergoing total ankle replacement surgery at The Ottawa Hospital will be randomly assigned to receive either TXA or a placebo (salt water solution). Neither the patients nor their health care team will know which treatment was given until the study is complete. All patients will receive standard surgical care and follow-up regardless of which group they are assigned to. Researchers will then collect information about wound healing, complications, additional surgeries, and infections at routine follow-up visits for up to six months after surgery.
The outcomes will be compared between patients in each group. The results of this pilot study will help determine whether a larger clinical trial is feasible and may provide early information about whether TXA could improve recovery after total ankle replacement surgery. Ultimately, this research aims to improve patient outcomes and reduce complications following ankle replacement surgery.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
This study is a randomized, double-blind, placebo-controlled pilot trial designed to determine the feasibility of conducting a definitive multicentre randomized controlled trial evaluating intravenous and topical tranexamic acid (TXA) for reducing postoperative wound complications following primary total ankle replacement (TAR). The trial will also collect preliminary safety and clinical outcome data to estimate the potential effect of TXA on postoperative wound complications.
Patients with ankle arthritis scheduled to undergo primary TAR will be screened for eligibility and enrolled after providing informed consent. Participants will be randomized in a 1:1 ratio to receive either intravenous and topical TXA or placebo (normal saline) administered according to the study protocol. Participants, treating surgeons, clinical staff, outcome assessors, and investigators will remain blinded to treatment allocation throughout the study.
All participants will undergo standard perioperative management and postoperative care as determined by their treating surgeon. Follow-up assessments will occur according to the routine postoperative schedule through six months after surgery. Data collected will include participant demographics, medical history, operative characteristics, study drug compliance, adverse events, and clinical outcomes.
The primary objective of this pilot trial is to determine the feasibility of conducting a definitive multicentre randomized controlled trial. Feasibility outcomes include participant recruitment, protocol adherence, treatment compliance, retention, completeness of follow-up, and completeness of outcome data collection.
Secondary objectives are to obtain preliminary estimates of the effect of intravenous TXA on postoperative wound complications and other clinically relevant outcomes, including surgical site infection, reoperation, blood transfusion, thromboembolic events, hospital readmission, and patient-reported outcome measures. Safety outcomes, including adverse events and serious adverse events, will also be monitored throughout the study.
The results of this pilot study will inform the design and implementation of a future adequately powered multicentre randomized controlled trial evaluating the effectiveness of intravenous TXA in improving outcomes following total ankle replacement.
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 2
Контакты и местонахождение
Контакты исследования
- Имя: Clinical Research Coordinator, MSc
- Номер телефона: 19217 6137378899
- Электронная почта: hghaziasgar@ohri.ca
Учебное резервное копирование контактов
- Имя: Clinical Research Coordinator, BSc
- Электронная почта: marleclerc@ohri.ca
Места учебы
-
-
Ontario
-
Ottawa, Ontario, Канада, K1Y 4E9
- The Ottawa Hospital Civic Campus
-
Контакт:
- Clinical Research Coordinator
- Номер телефона: 19217 6137378899
- Электронная почта: hghaziasgar@ohri.ca
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Patient undergoing either primary or revision ankle replacement surgery
- Patient is considered to benefit from surgical management at the treating surgeon's discretion
- The patient is willing and able to provide written informed consent
- The patient is willing and able to comply with post-operative rehabilitation protocols and all follow-up visits
Exclusion Criteria:
- Pregnant or breastfeeding patient
- Uncontrolled diabetes (HgbA1C > 8)
- Known allergy or contraindication for tranexamic acid use including: presence of coronary stents, cerebrovascular event in the last six months, known thromboembolic disorder, hepatic dysfunction, impaired renal clearance, medications with known drug interactions***
- Lateral-based ankle replacement system
- Patient receiving anticoagulation therapy
- Investigator concerns about study compliance
- Medically unfit for surgery or anesthetic
Acquired color vision problems that are not genetics
- There are potential drug-drug interactions leading to myocardial infarction after coadministration of tranexamic acid with hormonal contraceptives, hydrochlorothiazide, desmopressin, sulbactam-ampicillin, carbazochrome, ranitidine, or nitroglycerin. Therefore, patients on these medications will be excluded.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: TXA
Patients will receive 1.5g of TXA in 100ml normal saline (NS) solution intravenously within our hour prior to skin incision, and prior to tourniquet inflation.
A second dose of 3g in 100ml NS of tranexamic acid will be given topically through a soaked sponge after implant placement and prior to closure.
This will be left in place for five minutes.
|
Patients in the intervention group will receive 1.5g of TXA in 100ml normal saline (NS) solution.
A second dose of 3g in 100ml NS of tranexamic acid will be given topically through a soaked sponge.
|
|
Плацебо Компаратор: Placebo
Patients will receive either 100ml normal saline (NS) solution intravenously within our hour prior to skin incision, and prior to tourniquet inflation.
Then, a 100ml normal saline solution will be given topically through a soaked sponge after implant placement and prior to closure.
This will be left in place for five minutes.
|
Patients in the placebo group will receive 100ml normal saline (NS) solution intravenously.
A second dose of 100ml normal saline will be given topically through a soaked sponge.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Recruitment rate
Временное ограничение: 12 months
|
The primary feasibility outcome measure of the pilot trial is the overall recruitment rate based on the total recruitment over 12 months
|
12 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Treatment Fidelity
Временное ограничение: 6 months
|
A secondary feasibility outcome of the pilot trial is treatment fidelity, defined by adherence to study drug assignment and pilot trial protocol over 6 months of study involvement.
|
6 months
|
|
Retention Rate
Временное ограничение: 6 months
|
A secondary feasibility outcome of the pilot trial is retention rate, defined by participant completion of the pilot trial protocol over 6 months follow-up.
|
6 months
|
|
Consent Rate
Временное ограничение: 12 months
|
A secondary feasibility outcomes of the pilot trial include is consent rates for eligible participants who are approached over 12 months, including reasons for non-consent.
|
12 months
|
|
Trial Implementation Barriers
Временное ограничение: 12 months
|
A secondary feasibility outcome of the pilot trial is trial implementation barriers.
These include data capture and study management barriers, study team infrastructure challenges, participant- and site-level challenges, intervention-related challenges, and longitudinal study design challenges.
Outcomes categorized as not requiring major protocol changes, minor amendable protocol changes, or significant design/safety concerns.
|
12 months
|
|
Wound Complications
Временное ограничение: 6 months
|
A secondary clinical outcome measure, to be studied further in the definitive trial, is wound complications.
Wounds will be assessed at 2 weeks, 6 weeks, 3 months, and 6 months.
Each wound will be given a grade from zero to seven, as defined by the Foot and Ankle Postoperative Wound Classification scheme by Schipper et al.
Wounds will be graded by two different assessors.
|
6 months
|
|
Re-operation Rate
Временное ограничение: 6 months
|
A secondary clinical outcome measure, to be studied further in the definitive trial, is re-operation rate.
Relevant re-operations included will be for any subsequent surgery related to the TAR procedure, including wound-related debridement, prosthetic revision surgery (including any component revision) and others.
Re-operations within 6 months of primary surgery will be included.
|
6 months
|
|
Prosthetic Joint Infection
Временное ограничение: 6 months
|
A secondary clinical outcome measure, to be studied further in the definitive trial, is prosthetic joint infections.
Prosthetic joint infection will be defined as any infection that is confirmed by culture swab and treated with antibiotics.
Infections will be subdivided into superficial infections (swab positive superficial to fascia) and deep infections (swab positive in direct contact with the prosthesis).
Infections will be included up to 6 months from primary surgery.
|
6 months
|
|
Venous Thromboembolism
Временное ограничение: 6 months
|
VA secondary clinical outcome measure, to be studied further in the definitive trial, is venous thromboembolism (VTE) events.
VTE events will be captured based on confirmation on investigation with either lower extremity doppler ultrasound for lower extremity deep vein thrombosis, or chest helical CT or ventilation/perfusion scan for investigation for pulmonary embolism.
Events will be included within 6 months of primary surgery.
|
6 months
|
Соавторы и исследователи
Следователи
- Главный следователь: Bradley Meulenkamp, MD MSc FRCSC, The Ottawa Hospital
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 4224
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .