Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

APEX-STROKE EAGLE Domain (EAGLE) (EAGLE)

24 août 2026 mis à jour par: 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.

Aperçu de l'étude

Type d'étude

Interventionnel

Inscription (Estimé)

878

Phase

  • Phase 3

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  1. Age ≥ 18 years;
  2. Confirmed diagnosis of spontaneous supratentorial intracerebral hemorrhage (ICH) via cerebral imaging;
  3. 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;
  4. Hematoma volume ranging from 20 to 80 mL;
  5. National Institutes of Health Stroke Scale (NIHSS) score ≥ 8;
  6. Glasgow Coma Scale (GCS) score ≥ 8;
  7. Provision of written informed consent (or signed by an authorized representative).

Exclusion Criteria:

  1. Secondary causes of hemorrhage (e.g., structural abnormalities including arteriovenous malformations, cerebral aneurysms, tumors, trauma) or hemorrhagic transformation of acute ischemic stroke;
  2. Isolated intraventricular hemorrhage, or brainstem/cerebellar hemorrhage;
  3. Severe chronic kidney disease or liver failure;
  4. High risk of mortality within 7 days, or poor adherence to study treatment or follow-up;
  5. 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;
  6. Other conditions judged by the investigator to be unsuitable for MIS (e.g., brain herniation, etc.);
  7. Definite indications or contraindications for antihypertensive therapy of different intensities;
  8. Specific contraindications to any component of the planned antihypertensive medications (e.g., patients with allergy or hypersensitivity to any ingredient);
  9. 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.;
  10. 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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
  1. Early Minimally Invasive Surgery (MIS): Minimally invasive surgery (needle aspiration/minimally invasive hematoma evacuation) shall be initiated as soon as practicable post-randomization, with a mandatory initiation window within 8 hours of symptom onset; postoperative residual hematoma volume shall be controlled to < 10 mL.
  2. Intensive Blood Pressure Management: Antihypertensive therapy shall be initiated immediately post-randomization and must be implemented preoperatively. Systolic blood pressure (SBP) shall be titrated to the target range of 130-140 mmHg within 1 hour and maintained at this target for 72 hours post-randomization (sustained throughout the entire perioperative period).
  3. Hemostatic Therapy: Tranexamic acid (TXA) shall be administered immediately post-randomization: a loading dose of 1 g diluted in 100 mL of fluid, infused intravenously over 10 minutes; followed by a continuous intravenous infusion of 1 g in 250 mL of fluid over 8 hours.
Comparateur actif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Utility-Weighted Modified Rankin Scale (UW-mRS) Score at 6 Months
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
National Institutes of Health Stroke Scale (NIHSS) Score
Délai: 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
Délai: 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
Poor Functional Outcome
Délai: 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
Délai: 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
Délai: 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
Délai: 180 days
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L).
180 days

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

30 juin 2029

Achèvement de l'étude (Estimé)

28 février 2030

Dates d'inscription aux études

Première soumission

24 août 2026

Première soumission répondant aux critères de contrôle qualité

24 août 2026

Première publication (Réel)

27 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

27 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner