- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07790354
APEX-STROKE EAGLE Domain (EAGLE) (EAGLE)
24. August 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Geschätzt)
878
Phase
- Phase 3
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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).
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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.
|
|
|
Aktiver Komparator: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Utility-Weighted Modified Rankin Scale (UW-mRS) Score at 6 Months
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
National Institutes of Health Stroke Scale (NIHSS) Score
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 180 days
|
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L).
|
180 days
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. September 2026
Primärer Abschluss (Geschätzt)
30. Juni 2029
Studienabschluss (Geschätzt)
28. Februar 2030
Studienanmeldedaten
Zuerst eingereicht
24. August 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
24. August 2026
Zuerst gepostet (Tatsächlich)
27. August 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
27. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
24. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- APEX-STROKE_EAGLE DOMAIN
Plan für individuelle Teilnehmerdaten (IPD)
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JA
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Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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