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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Clinical Research Coordinator, MSc
- 電話番号：19217 6137378899
- メール：hghaziasgar@ohri.ca
研究連絡先のバックアップ
- 名前：Clinical Research Coordinator, BSc
- メール：marleclerc@ohri.ca
研究場所
-
-
Ontario
-
Ottawa、Ontario、カナダ、K1Y 4E9
- The Ottawa Hospital Civic Campus
-
コンタクト：
- Clinical Research Coordinator
- 電話番号：19217 6137378899
- メール：hghaziasgar@ohri.ca
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
プラセボコンパレーター：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Recruitment rate
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Treatment Fidelity
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Bradley Meulenkamp, MD MSc FRCSC、The Ottawa Hospital
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。