APEX-STROKE EAGLE Domain (EAGLE) (EAGLE)
Early Surgical Bundle for Intracerebral Hemorrhage (EAGLE) Domain of the APEX-STROKE Adaptive Platform Trial
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Fase 3
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
|
Comparatore attivo: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Utility-Weighted Modified Rankin Scale (UW-mRS) Score at 6 Months
Lasso di tempo: 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
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
National Institutes of Health Stroke Scale (NIHSS) Score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 180 days
|
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L).
|
180 days
|
Collaboratori e investigatori
Sponsor
Sponsor
Collaboratori
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- APEX-STROKE_EAGLE DOMAIN
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .