Extended Post-operative Oral TXA in Primary THA
6 de julho de 2026 atualizado por: Ryland Kagan, Oregon Health and Science University
Extended Post-operative Oral TXA vs.Standard Perioperative TXA in Primary TJA: A Randomized, Double-Blind, Placebo-Controlled Trial
The goal of this clinical trial is to learn if extended post-operative oral tranexamic acid (TXA) - a medication that reduces bleeding by slowing the breakdown of blood clots - can improve functional recovery following surgery in adults undergoing primary total knee or hip arthroplasty for osteoarthritis.
The main question it aims to answer is: Does extended post-operative oral TXA improve functional outcomes at 6 weeks post-operatively compared to standard perioperative TXA alone?
Researchers will compare patients receiving extended oral TXA to patients receiving matching placebo capsules on the same schedule to see if the extended TXA regimen reduces blood loss, improves early functional outcomes, and reduces pain without increasing complication rates.
Participants will receive standard perioperative oral TXA (1.95 g) prior to surgical incision, along with standard VTE prophylaxis.
They will be randomly assigned to receive either oral TXA or matching placebo capsules once daily on post-operative days 1, 2, and 3. Participants will attend follow-up visits at 2, 6, and 12 weeks post-operatively to complete functional outcome questionnaires, pain assessments, and - for knee replacement patients - range of motion measurements.
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
170
Estágio
- Fase 4
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Ryland Kagan, MD
- Número de telefone: 503 494-6400
- E-mail: kagan@ohsu.edu
Estude backup de contato
- Nome: Madison Hayes-Lattin, MD
- Número de telefone: 503) 494-6400
- E-mail: hayeslam@ohsu.edu
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Age ≥18 years
- Undergoing primary total knee arthroplasty (TKA) or total hip arthroplasty (THA) for osteoarthritis
- Ability to provide written informed consent
- Willingness to comply with study protocol
Exclusion Criteria:
- History of venous thromboembolism (DVT or PE)
- Active malignancy
- Allergy or contraindication to tranexamic acid (TXA)
- Post-operative anticoagulation therapy other than aspirin
- History of color blindness or retinal disease
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Extended Oral TXA
Participants will receive standard 1.95mg pre-operative oral TXA dose in addition to 1.95mg oral TXA on post-operative days 1, 2, and 3.
|
Participants in the intervention group will receive 1.95mg of oral tranexamic acid on post-operative day 1, 2, and 3.
|
|
Comparador de Placebo: Placebo
Patients will receive standard pre-operative 1.95mg oral TXA, followed by a placebo pill on post-operative days 1, 2 and 3.
|
Patients will receive an oral placebo medication on post-operative day 1, 2, and 3.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
6-week Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) score
Prazo: At 6 weeks from timing of surgical intervention
|
Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) for patients undergoing Total Knee Arthroplasty or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) for patients undergoing Total Hip Arthroplasty at 6 weeks post-operatively.
Scale for booth outcome scores is 0 to 100, with a higher score representing improved patient-reported knee or hip health.
|
At 6 weeks from timing of surgical intervention
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
6-week absolute knee flexion
Prazo: At 6 weeks from timing of surgical intervention
|
Degrees of knee flexion achieved at the 6 week post-operative mark for patients undergoing Total Knee Arthroplasty
|
At 6 weeks from timing of surgical intervention
|
|
Transfusion rate
Prazo: From enrollment to end of treatment at 12 weeks from timing of surgical intervention
|
Percentage of patients per arm requiring post-operative transfusion of blood products
|
From enrollment to end of treatment at 12 weeks from timing of surgical intervention
|
|
Blood product units transfused
Prazo: From enrollment to end of treatment at 12 weeks from timing of surgical intervention
|
For each arm, the average number of blood product units transfused per patient
|
From enrollment to end of treatment at 12 weeks from timing of surgical intervention
|
|
Incidence of Symptomatic DVT
Prazo: From enrollment to end of treatment at 90 days from timing of surgical intervention
|
The number of post-operative symptomatic deep vein thromboses identified in each arm
|
From enrollment to end of treatment at 90 days from timing of surgical intervention
|
|
Incidence of Symptomatic PE
Prazo: From enrollment to end of treatment at 90 days from timing of surgical intervention
|
The number of post-operative symptomatic pulmonary embolisms identified in each arm
|
From enrollment to end of treatment at 90 days from timing of surgical intervention
|
|
Incidence of Acute Coronary Sndrome
Prazo: From enrollment to end of treatment at 90 days from timing of surgical intervention
|
The number of cases of post-operative acute coronary syndrome, defined as an ST-elevation myocardial infarction (STEMI), a non-ST-elevation myocardial infarction (NSTEMI), or unstable angina.
|
From enrollment to end of treatment at 90 days from timing of surgical intervention
|
|
Incidence of Cerebrovascular Accident
Prazo: From enrollment to end of treatment at 90 days from timing of surgical intervention
|
The number of post-operative cerebrovascular accidents (CVAs), defined as ischemic or hemorrhagic stroke.
|
From enrollment to end of treatment at 90 days from timing of surgical intervention
|
|
Rate of Readmission
Prazo: From enrollment to end of treatment at 12 weeks from timing of surgical intervention
|
The number of patients per arm requiring readmission for any reason within 90 days of surgical intervention.
|
From enrollment to end of treatment at 12 weeks from timing of surgical intervention
|
|
Rate of Reoperation
Prazo: From enrollment to end of treatment at 90 days from timing of surgical intervention
|
The number of patients per arm requiring reoperation for any indication within 90 days of surgical intervention.
|
From enrollment to end of treatment at 90 days from timing of surgical intervention
|
|
All-cause Mortality Rate
Prazo: From enrollment to end of treatment at 90 days from timing of surgical intervention
|
The number of patients deceased of any cause within 90 days of surgical intervention.
|
From enrollment to end of treatment at 90 days from timing of surgical intervention
|
|
2-week Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) score
Prazo: At 2 weeks from timing of surgical intervention
|
Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) for patients undergoing Total Knee Arthroplasty or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) for patients undergoing Total Hip Arthroplasty at 2 weeks post-operatively.
Scale for both outcome scores is 0 to 100, with a higher score representing improved patient-reported knee or hip health.
|
At 2 weeks from timing of surgical intervention
|
|
12-week Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) score
Prazo: At 12 weeks from timing of surgical intervention
|
Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) for patients undergoing Total Knee Arthroplasty or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) for patients undergoing Total Hip Arthroplasty at 12 weeks post-operatively.
Scale for both outcome scores is 0 to 100, with a higher score representing improved patient-reported knee or hip health.
|
At 12 weeks from timing of surgical intervention
|
|
2-week Visual Analog Scale (VAS) pain score
Prazo: At 2 weeks from timing of surgical intervention
|
Visual analog scale (VAS) pain score at 2 weeks post-operatively.
Scale is 0-10 with higher scores representing more pain.
|
At 2 weeks from timing of surgical intervention
|
|
6-week Visual Analog Scale (VAS) pain score
Prazo: At 6 weeks from timing of surgical intervention
|
Visual analog scale (VAS) pain score at 6 weeks post-operatively.
Scale is 0-10 with higher scores representing more pain.
|
At 6 weeks from timing of surgical intervention
|
|
12-week Visual Analog Scale (VAS) pain score
Prazo: At 12 weeks from timing of surgical intervention
|
Visual analog scale (VAS) pain score at 12 weeks post-operatively.
Scale is 0-10 with higher scores representing more pain.
|
At 12 weeks from timing of surgical intervention
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de setembro de 2026
Conclusão Primária (Estimado)
1 de março de 2028
Conclusão do estudo (Estimado)
1 de setembro de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
29 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de junho de 2026
Primeira postagem (Real)
6 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
8 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
6 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 30119
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .