- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07790354
APEX-STROKE EAGLE Domain (EAGLE) (EAGLE)
24 de agosto de 2026 atualizado por: Fudan University
Early Surgical Bundle for Intracerebral Hemorrhage (EAGLE) Domain of the APEX-STROKE Adaptive Platform Trial
In this domain of APEX-STROKE, participants with acute spontaneous supratentorial intracerebral haemorrhage (ICH) who meet the domain-specific eligibility criteria will be randomised to either an early surgical bundle or guideline-based standard care.
Intervention: Early minimally invasive surgery (MIS) shall be initiated within 8 hours of symptom onset; intensive systolic blood pressure control (target range: 130-140 mmHg) shall be achieved within 1 hour post-randomization and maintained for 72 hours post-randomization; tranexamic acid (TXA) hemostatic therapy: A 1-g loading dose shall be intravenously infused over 10 minutes, followed by an 8-hour continuous intravenous infusion of a 1-g maintenance dose; the entire regimen must be initiated within 30 minutes post-randomization.
Control condition: All patient management shall strictly adhere to local institutional guidelines for intracerebral hemorrhage (ICH) diagnosis and treatment; MIS is recommended to be prohibited within 12 hours of symptom onset (except for emergency life-saving surgery); blood pressure management shall be conducted in accordance with local guidelines; the use of TXA is not recommended.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
878
Estágio
- Fase 3
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;
- Confirmed diagnosis of spontaneous supratentorial intracerebral hemorrhage (ICH) via cerebral imaging;
- Randomization completed within 6 hours of symptom onset (or last known normal state), with the ability to initiate MIS within 8 hours of ICH onset;
- Hematoma volume ranging from 20 to 80 mL;
- National Institutes of Health Stroke Scale (NIHSS) score ≥ 8;
- Glasgow Coma Scale (GCS) score ≥ 8;
- Provision of written informed consent (or signed by an authorized representative).
Exclusion Criteria:
- Secondary causes of hemorrhage (e.g., structural abnormalities including arteriovenous malformations, cerebral aneurysms, tumors, trauma) or hemorrhagic transformation of acute ischemic stroke;
- Isolated intraventricular hemorrhage, or brainstem/cerebellar hemorrhage;
- Severe chronic kidney disease or liver failure;
- High risk of mortality within 7 days, or poor adherence to study treatment or follow-up;
- Severe comorbidities (e.g., cancer, chronic obstructive pulmonary disease, heart failure, significant pre-stroke disability [modified Rankin Scale (mRS) score 3-5]) that may confound outcome assessment;
- Other conditions judged by the investigator to be unsuitable for MIS (e.g., brain herniation, etc.);
- Definite indications or contraindications for antihypertensive therapy of different intensities;
- Specific contraindications to any component of the planned antihypertensive medications (e.g., patients with allergy or hypersensitivity to any ingredient);
- Patients with contraindications to tranexamic acid (TXA), including: those allergic or hypersensitive to TXA or its excipients, patients with active thrombotic disorders, individuals with hereditary or acquired thrombophilia, patients with subarachnoid hemorrhage, and those with upper urinary tract bleeding complicated by gross hematuria, etc.;
- Patients known at enrollment to be receiving therapeutic anticoagulation with warfarin or low-molecular-weight heparin (users of direct oral anticoagulants are eligible for inclusion and not excluded).
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: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Experimental: Early Surgical Bundle
Participants in this arm receive an early surgical bundle consisting of minimally invasive surgery (MIS), intensive blood pressure management, and tranexamic acid (TXA) haemostatic therapy, in addition to guideline-based standard care for acute spontaneous supratentorial intracerebral haemorrhage.
|
|
|
Comparador Ativo: Active Comparator: Guideline-Based Standard Care
Participants in this arm receive guideline-based standard care for acute spontaneous supratentorial intracerebral haemorrhage.
Clinical assessment, investigations, monitoring, blood pressure management, surgical decisions, and supportive treatment are determined by the treating clinical team according to local institutional guidelines.
TXA should be avoided.
If surgery is required, it should generally be initiated ≥12 hours after ICH symptom onset unless emergency life-saving surgery is clinically necessary.
Surgery is not recommended for participants with a haematoma volume of 20-30 mL.
|
Guideline-based standard care for acute intracerebral haemorrhage is provided according to local institutional guidelines.
Treatment decisions, including monitoring, blood pressure management, neurosurgical intervention, vasoactive support, mechanical ventilation, fluid therapy, and other supportive care, are determined by the treating clinical team.
TXA should be avoided.
If surgery is clinically required, it should generally be initiated ≥12 hours after ICH symptom onset unless emergency life-saving surgery is necessary.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Utility-Weighted Modified Rankin Scale (UW-mRS) Score at 6 Months
Prazo: 180 days
|
Functional outcome will be assessed using the utility-weighted modified Rankin Scale (UW-mRS) by a trained central assessor blinded to treatment allocation.
The UW-mRS incorporates the functional health states represented by the modified Rankin Scale into a utility-weighted measure of overall functional outcome.
|
180 days
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
National Institutes of Health Stroke Scale (NIHSS) Score
Prazo: 24 hours after randomization, 7 days after randomization or earlier at hospital discharge
|
Neurological impairment will be assessed using the National Institutes of Health Stroke Scale (NIHSS).
Higher scores indicate greater neurological impairment.
|
24 hours after randomization, 7 days after randomization or earlier at hospital discharge
|
|
Rebleeding
Prazo: Within 7 days after randomization or earlier at hospital discharge
|
The occurrence of rebleeding will be assessed during the early post-randomization period.
The outcome will be reported as the number and proportion of participants experiencing a rebleeding event.
|
Within 7 days after randomization or earlier at hospital discharge
|
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Poor Functional Outcome
Prazo: 180 days
|
Poor functional outcome will be defined as a modified Rankin Scale (mRS) score of 3-6.
The outcome will be reported as the number and proportion of participants with mRS scores of 3-6.
|
180 days
|
|
Mortality
Prazo: 180 days
|
Mortality will be assessed as the number and proportion of participants who have died from any cause during follow-up.
|
180 days
|
|
Disability
Prazo: 180 days
|
Disability will be defined as a modified Rankin Scale (mRS) score of 3-5 and will be reported as the number and proportion of participants meeting this criterion.
|
180 days
|
|
Health-Related Quality of Life Assessed by EQ-5D-5L
Prazo: 180 days
|
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L).
|
180 days
|
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)
30 de junho de 2029
Conclusão do estudo (Estimado)
28 de fevereiro de 2030
Datas de inscrição no estudo
Enviado pela primeira vez
24 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
24 de agosto de 2026
Primeira postagem (Real)
27 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
27 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
24 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- APEX-STROKE_EAGLE DOMAIN
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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