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- Ensaio Clínico NCT01940523
Randomized Controlled Trial of Tranexamic Acid in Total Knee Arthroplasty: Intravenous vs. Topical
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This randomized controlled trial compares the blood loss of patients undergoing unilateral total knee replacements who randomly receive either the topical or the intravenous form of tranexmamic acid during surgery. Patients in the intravenous arm of the study will receive 1 gram of tranexamic acid in 10 milliliters of solution prior to inflation of the tourniquet and 1 gram of tranexamic acid in 10 milliliters of solution during closure. For patients in the topical arm of the study, prior to the release of the tourniquet they will receive 3 grams of tranexamic acid in 75ccs of solution directly on the site of the incision.
The primary result measurement will be blood drain output from the knee at 24 hours after surgery.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55902
- Mayo Clinic
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New York
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New York, New York, Estados Unidos, 10021
- Hospital for Special Surgery
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Primary total knee replacmeent
- Osteoarthritis
- Unilateral
Exclusion Criteria:
- Revision surgery
- Donated preoperative autologous blood
- On chronic anticoagulation medication such as Coumadin, Xarelto, Plavix, or Aspirin (other than 81mg)
- Preoperative hepatic or renal dysfunction
- Diagnosis of inflammatory disease
- Diagnosis of inflammatory arthritis
- Pregnant
- Breastfeeding
- Preoperative hemoglobin <10g/dL
- International Normalized Ratio>1.4
- Abnormal Partial Thromboplastin Time
- Preoperative platelet count of <150,000mm^3
- Creatinine > 1.4
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: Topical Tranexamic Acid
3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution).
This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).
The solution will be left in contact with the tissues for five minutes.
The surgeon will suction away excess solution.
The site may be irrigated before or after the tranexamic acid bath as long as the solution is in contact for at least five full minutes.
After that, the tourniquet will be released and the rest of the surgery will proceed according to the standard of care.
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3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution).
This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).
The solution will be left in contact with the tissues for five minutes.
The surgeon will suction away excess solution.
The site may be irrigated before or after the tranexamic acid bath as long as the solution is in contact for at least five full minutes.
After that, the tourniquet will be released and the rest of the surgery will proceed according to the standard of care.
|
Comparador Ativo: Intravenous Tranexamic Acid
1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet.
A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.
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1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet.
A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Total Blood Loss
Prazo: during surgery
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The amount of blood lost during surgery is the primary outcome measure.
Blood loss is determineusing an equation that calculates the patient's blood volume based on their height and weight, then multiplies the patient's blood volume by the change in their hematocrit after surgery compared to before surgery.
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during surgery
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Drain Output
Prazo: from end of surgery to 24 hours postoperatively
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The amount of blood collected by a drain attached to the knee is measured 24 hours after surgery.
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from end of surgery to 24 hours postoperatively
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The Number Patients Requiring a Transfusion
Prazo: over course of hospital stay (averaging three days)
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TThe number Patients requiring a transfusion over the course of the patient's hospital stay.
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over course of hospital stay (averaging three days)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: David Mayman, MD, Hospital for Special Surgery, New York
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 12166
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