- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07621185
Manual vs Pneumatic Compression to Prevent Radial Artery Occlusion After Transradial Procedures (RADIAL-HEMO)
Manual Radial Compression Versus Gradual Pneumatic Compression for the Prevention of Radial Artery Occlusion After Transradial Cardiac Catheterization: A Pragmatic Multicenter Study
This study evaluates two commonly used methods of achieving hemostasis after transradial cardiac catheterization: manual compression and pneumatic compression with gradual deflation.
Transradial access is widely used for diagnostic and interventional cardiac procedures due to its safety profile, but radial artery occlusion remains a relevant complication that may limit future vascular access.
In this pragmatic, prospective, multicenter study conducted in routine clinical practice, adult patients undergoing transradial cardiac catheterization were assigned to receive either manual compression or pneumatic compression using a standardized patent hemostasis protocol. The primary objective is to compare the incidence of radial artery occlusion at 30 days between both strategies.
Secondary outcomes include local vascular complications, patient-reported pain, and total compression time.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Transradial access has become the preferred approach for diagnostic and interventional coronary procedures due to its association with reduced bleeding complications, earlier mobilization, and shorter hospital stay compared with transfemoral access. However, radial artery occlusion (RAO) remains a relevant access-site complication that may limit future vascular access or the use of the radial artery as a conduit for coronary artery bypass grafting.
Hemostasis following radial sheath removal is a critical step in preserving arterial patency. Two commonly used strategies include manual compression using sterile gauze and non-circumferential adhesive dressing, and pneumatic compression using dedicated mechanical devices typically applied with gradual deflation protocols. Both approaches aim to achieve effective hemostasis while maintaining antegrade arterial flow, a concept known as patent hemostasis.
This study was designed as a pragmatic, prospective, multicenter interventional study conducted across eight hospitals in Spain, with central coordination from Hospital Clinic of Barcelona. The objective was to compare the effectiveness and safety of manual radial compression versus pneumatic compression with gradual deflation under standardized patent hemostasis protocols in real-world clinical practice.
Consecutive adult patients undergoing diagnostic or interventional cardiac catheterization via transradial access were included. After sheath removal, participants were assigned in a 1:1 predefined alternating sequence to either manual compression or pneumatic compression strategies.
In the manual compression group, hemostasis was achieved using direct pressure with sterile gauze and a non-circumferential adhesive dressing, with progressive adjustment of pressure to maintain arterial patency assessed by plethysmography. In the pneumatic compression group, a dedicated compression device was applied and gradually deflated according to a standardized protocol to achieve patent hemostasis.
The primary outcome was radial artery occlusion at 30 days, defined as absence of distal plethysmographic signal during radial artery compression assessed using the Barbeau test. Secondary outcomes included local vascular complications (such as hematoma, persistent bleeding, or pseudoaneurysm), patient-reported pain assessed using a visual analog scale (VAS), and total compression time.
All participating centers followed a unified protocol, and hemostasis procedures were performed by trained nursing staff. The study was designed to reflect routine clinical practice conditions and to evaluate whether clinical outcomes are primarily influenced by the type of compression strategy or by the standardized implementation of patent hemostasis protocols.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Barcelona, Espanha, 08036
- Hospital Clinic of Barcelona
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Adults aged ≥18 years
- Undergoing diagnostic or interventional cardiac catheterization via transradial access
- Preserved dual hand circulation confirmed by Barbeau test
- Ability to provide informed consent
- Ability to complete 30-day follow-up
Exclusion Criteria:
- Refusal to participate
- Inability to complete follow-up
- Abnormal collateral circulation (Barbeau type D)
- Initial failure of radial access
- Contraindication to prolonged radial compression
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Manual Compression
Hemostasis achieved by direct manual compression using sterile gauze and a non-circumferential adhesive dressing, with progressive adjustment of pressure to maintain arterial patency.
Compression duration was approximately 3-4 hours depending on the procedure.
|
Direct manual compression using sterile gauze and a non-circumferential adhesive dressing applied after radial sheath removal, with progressive pressure adjustment to achieve patent hemostasis.
|
|
Experimental: Pneumatic Compression
Hemostasis achieved using a pneumatic compression device with gradual deflation following a standardized patent hemostasis protocol, ensuring bleeding control while maintaining arterial flow.
The device was progressively deflated until complete removal.
|
Application of a pneumatic compression device with gradual deflation following a standardized patent hemostasis protocol to maintain arterial flow while achieving hemostasis.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Radial Artery Occlusion
Prazo: 30 days
|
Radial artery occlusion assessed by absence of distal plethysmographic signal during radial artery compression using the Barbeau test.
|
30 days
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Local Vascular Complications
Prazo: During hospital stay and up to 30 days
|
Incidence of access-site complications including hematoma, persistent bleeding, pseudoaneurysm, or other local vascular complications.
|
During hospital stay and up to 30 days
|
|
Pain During Compression
Prazo: Immediately after compression
|
Patient-reported pain during the compression period assessed using a visual analog scale (VAS).
|
Immediately after compression
|
|
Total Compression Time
Prazo: During procedure
|
Total duration of radial compression measured in minutes from sheath removal to device or dressing removal.
|
During procedure
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Montserrat Pardo, RN, Hospital Clinic of Barcelona
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 (Real)
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
- HCB-RAO-HEMOSTASIS-2022
- HCB/2021/1166 (Outro identificador: Clinical Research Ethics Committee of Hospital Clínic of Barcelona)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .