- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07790354
APEX-STROKE EAGLE Domain (EAGLE) (EAGLE)
24 de agosto de 2026 actualizado 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
878
Fase
- Fase 3
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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).
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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 activo: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Utility-Weighted Modified Rankin Scale (UW-mRS) Score at 6 Months
Periodo de tiempo: 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.
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180 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
National Institutes of Health Stroke Scale (NIHSS) Score
Periodo de tiempo: 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
|
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Rebleeding
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
30 de junio de 2029
Finalización del estudio (Estimado)
28 de febrero de 2030
Fechas de registro del estudio
Enviado por primera vez
24 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
24 de agosto de 2026
Publicado por primera vez (Actual)
27 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
24 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- APEX-STROKE_EAGLE DOMAIN
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .