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L'essai clinique NCT07118345 pour AVC ischémique, Œdème cérébral est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Early Prophylactic Decompressive Hemicraniectomy Following Endovascular Therapy in Large Hemispheric Infarct Trial 380

En recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT07118345 est une étude interventionnel pour AVC ischémique, Œdème cérébral. Son statut actuel est : en recrutement. L'étude a débuté le 19 juillet 2025 et vise à recruter 380 participants. Dirigée par Xuanwu Hospital, Beijing, l'étude devrait être terminée d'ici le 19 juin 2029. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 26 janvier 2026.
Résumé succinct
Early Decompressive Hemicraniectomy for High-Risk Large Ischemic Core Stroke Post-EVTAcute Ischemic Stroke (AIS), particularly Anterior Circulation Large Vessel Occlusion (LVO), is a major cause of global disability and death. While endovascular thrombectomy (EVT) is the standard first-line treatment for LVO, outcomes remain poor in patients with large ischemic cores (ASPECTS ≤5). Despite high recanalization rates (...Afficher plus
Titre officiel

Early Prophylactic Decompressive Hemicraniectomy Following Endovascular Therapy in Large Hemispheric Infarct Trial

Pathologies
AVC ischémiqueŒdème cérébral
Autres identifiants de l'étude
  • IAT-EPIC
Numéro NCT
Date de début (réel)
2025-07-19
Dernière mise à jour publiée
2026-01-26
Date de fin (estimée)
2029-06-19
Inscription (estimée)
380
Type d'étude
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
Acute Ischemic Stroke
Endovascular Thrombectomy
Cerebral Edema
Hemicraniectomy
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalExperimental group
Early prophylactic decompressive hemicraniectomy
Early prophylactic decompressive hemicraniectomy
Early prophylactic decompressive hemicraniectomy (decompressive hemicraniectomy is required to initiate within 6 hours after completion of mechanical thrombectomy and within 4 hours after randomization).
Aucune interventionControl group
Standard medical treatment (with or without rescue decompressive craniectomy if needed).
N/A
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
Rate of mRS score of 0-4
Rate of mRS score of 0-4
90 days (±7 days) after randomization
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
Rate of mRS score of 0-3 Ordinal shift analysis of mRS •Rate of mRS score of 0-2 •Rate of midline shift ≥ 5 mm •Rate of brain herniation Improvement of the NIHSS Rate of neurological deterioration Rate of rescue decompressive hemicraniectomy
mRS score ranges 0-6
90 days (±7 days) after randomization
Ordinal shift analysis of mRS
mRS score ranges 0-6
90 days (±7 days) after randomization
Rate of mRS score of 0-2
mRS score ranges 0-6
90 days (±7 days) after randomization
Rate of midline shift ≥ 5 mm
Based on imaging assessment (e.g., CT, MRI)
Within 72 hours after randomization
Rate of brain herniation
e.g., 1 or 2 dilated, fixed pupils; unconsciousness related to edema \[i.e., ≥2 on item 1a on the NIHSS\]; and/or loss of other brain stem reflexes, attributable to edema or herniation according to the Investigator's judgment
Within 72 hours after randomization
Improvement of the NIHSS
The NIHSS score range from 0 (no deficit) to 42 (maximum deficit)
5-7 days after randomization or discharge
Rate of neurological deterioration
Defined as increase of NIHSS score ≥4 from baseline
5-7 days after randomization or discharge
Rate of rescue decompressive hemicraniectomy
Control group
5-7 days after randomization or discharge
Length of ICU stay
Residual stay days of ICU
Perioperative
Length of hospitalization
Residual stay days of hospitalization
Perioperative
Barthel Index
The Barthel Index range from 0 (severe disability) to 100 (no disability)
90 days (±7 days) after randomization
Modified Rankin scale and Barthel Index
The mRS score range from 0 (no disability) to 6 (death), the Barthel Index range from 0 (severe disability) to 100 (no disability)
12 months (±30 days) after randomization
Rate of any intracranial hemorrhage (ICH)
The occurrence of ICH includes the following scenarios: 1. new occurrence of ICH; 2. progression of ICH based on Heidelberg Bleeding Classification.
Within 72 hours after randomization
Rate of parenchymal hematoma type 2 intracranial hemorrhage
Within 72 hours after randomization
Mortality
Defined as mRS 6
90 days (±7 days) after randomization
Serious Adverse Events
Detailled description noted in study protocol
90 days (±7 days) after randomization
Assistant à la participation
Critères d'éligibilité

  1. Premorbid mRS ≤1;
  2. Time from symptom onset to puncture ≤24 hours; including wake-up stroke and unwitnessed stroke. The time at which symptoms began was defined as the "Last Known Well" (LKW).

3.18 to 75 years of age; 4.Internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 occlusion confirmed by computed tomographic angiography (CTA)/ magnetic resonance angiography (MRA)/ digital subtraction angiography (DSA). Patients with involvement of ipsilateral anterior cerebral artery (ACA), MCA or embryonal posterior cerebral artery (PCA) are eligible for inclusion.

5.NIHSS1a ≥ 1 (with the clarification that changes in alertness cannot be attributable to cerebral edema); 6.Meeting any of the following criteria:

  1. ASPECTS 3-5 and NIHSS ≥ 30;
  2. ASPECTS 0-2; 7.Signs on CT/MRI of an infarct of at least 50% of the middle cerebral artery territory; 8.No midline shift or midline shift <5mm; 9.Mechanical Thrombectomy and successful recanalization (defined as eTICI ≥2b50); 10.Ability to initiate decompressive hemicraniectomy within 6 hours after completion of mechanical thrombectomy and within 4 hours after randomization; 11.Informed consent obtained from the patient or his/her legal representative.

Clinical Exclusion Criteria

  1. Any symptoms and signs of brain herniation before randomization, such as pupil anisocoria and unstable vital signs.
  2. In the judgment of the investigator, the subject is likely to have supportive care withdrawn in the first day.
  3. Commitment to decompressive hemicraniectomy (DHC) prior to enrollment.
  4. Severe, sustained hypertension (systolic blood pressure > 220 mm Hg or diastolic blood pressure > 110 mm Hg);
  5. Baseline blood glucose <50 mg/dl (2.8 mmol/L) or >400 mg/dl (22.2 mmol/L);
  6. Baseline platelet count <100 x10^9/L;
  7. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with international normalized ratio > 1.7;
  8. Severe renal insufficiency, defined as serum creatinine > 3.0 mg/dl (or 265.2 μmol/l) or glomerular filtration rate \[GFR\] < 30 ml/min, or patients requiring hemodialysis or peritoneal dialysis;
  9. Patients that cannot complete 90-day follow-up (such as no fixed residence, overseas patients, etc.);
  10. Suspected vasculitis or septic embolism;
  11. Neurological diseases or mental disorders before onset that affect the assessment of the condition;
  12. Females who are pregnant or in lactation;
  13. Participating in other clinical trials that could confound the evaluation of the study;
  14. Subjects who, in the opinion of the investigator, have a life expectancy <3 months due to conditions not related to current LHI or are unlikely to comply with follow-up requirements. Other conditions that the investigators believe are not suitable for participation or may pose a significant risk to the patient.

Neuroimaging Exclusion Criteria

  1. Evidence of other brain diseases such as cerebral trauma, intracranial tumor (except small meningioma), cerebral aneurysm, etc.
  2. Evidence of acute ischemic infarction in bilateral anterior circulation territory or involvement of posterior circulation territories (other than in patients with a fetal or near-fetal PCA configuration);
  3. Vascular perforation during thrombectomy;
  4. The pre-randomization CT findings exhibits evidence of parenchymal hemorrhage 2 intracranial hemorrhage, diffuse severe subarachnoid hemorrhage, or intraventricular hemorrhage. Patients with localized mild subarachnoid hemorrhage, hemorrhagic infarction type1 or 2, and small parenchymal hematoma type 1 without midline shift may be included;
Xuanwu Hospital, Beijing logoXuanwu Hospital, Beijing
Aucune donnée de contact disponible
2 Centres de l'étude dans 1 pays
Xuanwu Hospital, Capital Medical University., Beijing, China
Liqun Jiao, MD., Contact, 86+13911224991, [email protected]
Pas encore en recrutement
Liaocheng Brain Hospital, Shandong, China
Liyong Zhang, MD., Contact, 86+13346256936, [email protected]
En recrutement