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Associazione tra uso profilattico di farmaci per l'ulcera da stress e risultati clinici in pazienti con trombectomia acuta della circolazione anteriore

2 novembre 2026 aggiornato da: Nanfang Hospital, Southern Medical University

Associazione dell'uso profilattico dei farmaci per l'ulcera da stress e dei risultati clinici nei pazienti con trombectomia della circolazione anteriore acuta: uno studio di coorte prospettico, multicentrico e osservazionale

Ischemic stroke accounts for a relatively high proportion of strokes. In recent years, intravenous thrombolysis and endovascular therapy have significantly improved the revascularization rate in patients with large vessel occlusive cerebral infarction, but 20-50% of patients still experience ineffective revascularization. Therefore, postoperative monitoring and treatment of patients with large vessel occlusions is crucial for early recognition, management and prevention of complications. Stress ulcer bleeding is a serious complication after acute ischemic stroke, with a prevalence of 1%-5%, and a previously proven incidence of stress ulcer bleeding after ischemic stroke. Stress ulcer bleeding after ischemic stroke has been shown to be closely associated with unfavorable outcomes, such as mortality. Current national and international guidelines or consensus on the prevention of stress ulcers after acute ischemic stroke do not advocate the routine use of histamine receptor antagonists or proton pump inhibitors for the prevention of stress ulcers, but rather should be considered in the context of the patient's risk factors for stress ulcers and discontinued after the patient initiates enteral nutrition. However, there is no evidence-based medical evidence to support the risk-benefit relationship of stress ulcer drug prophylaxis in patients with mechanical thrombectomy for acute anterior circulation large vessel occlusion.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Ictus ischemico acuto

Descrizione dettagliata

Stress ulcer bleeding is a serious complication after acute ischemic stroke, with a prevalence of 1%-5%, of which only 0.5%-1% require blood transfusion or result in hypotension. Stress ulcer bleeding after ischemic stroke has been shown to be associated with poor outcomes, such as mortality, and basilar artery occlusion and middle cerebral artery cerebral infarction are independent risk factors for stress ulcer bleeding after acute ischemic stroke. Guidelines or consensus on the prevention of stress ulcers after acute ischemic stroke do not advocate the routine use of histamine receptor antagonists or proton pump inhibitors for stress ulcer prevention.

However, stress ulcer prophylaxis is initiated in most patients admitted to the neurological intensive care unit after mechanical embolization of acute anterior circulation large vessel occlusion. With advances such as diagnosis and early initiation of enteral nutrition, the rate of stress ulcer bleeding in patients with mechanical embolization of acute anterior circulation large vessel occlusion is significantly reduced. The relationship between the risk and benefit of SUP in patients undergoing mechanical embolization for acute anterior circulation large vessel occlusion is not yet supported by evidence-based medical evidence. Therefore, the purpose of this study was to investigate the correlation between pharmacological stress ulcer prophylaxis and clinical outcomes in patients undergoing mechanical thrombectomy for acute anterior circulation large vessel occlusion.

Tipo di studio

Osservativo

Iscrizione (Stimato)

2592

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Nome: Suyue Pan, M.D., Ph.D.
Numero di telefono: 13556184981
Email: pansuyue@smu.edu.cn

Luoghi di studio

Cina
- Fujian
  - Fuzhou, Fujian, Cina
    - Reclutamento
    - Fujian Medical University Union Hospital
    - Contatto:
      
      Shenggen Chen, M.D.
      
      Numero di telefono: 13459480275
- Guangdong
  - Dongguan, Guangdong, Cina
    - Reclutamento
    - Dongguan People's Hospital
    - Contatto:
      
      Zhu Shi, M.D.
      
      Numero di telefono: 13669825459
  - Dongguan, Guangdong, Cina
    - Reclutamento
    - Dongguan donghua hospital
    - Contatto:
      
      Lingyu Sun
      
      Numero di telefono: 13829203368
  - Guangzhou, Guangdong, Cina
    - Reclutamento
    - Nanfang Hospital of Southern Medical University
    - Contatto:
      
      Suyue Pan
      
      Numero di telefono: 13556184981
  - Guangzhou, Guangdong, Cina
    - Reclutamento
    - Guangdong Provincial Hospital of Traditional Chinese Medicine
    - Contatto:
      
      Lixin Wang, M.D.
      
      Numero di telefono: 13922793886
  - Guangzhou, Guangdong, Cina
    - Reclutamento
    - Huadu District People's Hospital of Guangzhou
    - Contatto:
      
      Guangning Li, M.D.
      
      Numero di telefono: 13926239656
  - Guangzhou, Guangdong, Cina
    - Reclutamento
    - The Fourth Affiliated Hospital of Guangzhou Medical University
    - Contatto:
      
      Wangchi Luo, M.D.
      
      Numero di telefono: 13710895142
  - Heyuan, Guangdong, Cina
    - Reclutamento
    - Heyuan people's Hospital
    - Contatto:
      
      Minzhen Zhu
      
      Numero di telefono: 15007622318
  - Huizhou, Guangdong, Cina
    - Reclutamento
    - Huizhou Municipal Central Hospital
    - Contatto:
      
      Lizhi Wang, M.D.
      
      Numero di telefono: 13802872076
- Hainan
  - Haikou, Hainan, Cina
    - Reclutamento
    - Hainan Provincial People's Hospital
    - Contatto:
      
      Fan Zhang, M.D.
      
      Numero di telefono: 17389897580
  - Haikou, Hainan, Cina
    - Reclutamento
    - Haikou People's Hospital
    - Contatto:
      
      Guoshuai Yang, M.D.
      
      Numero di telefono: 13876006248
  - Haikou, Hainan, Cina
    - Reclutamento
    - Hainan Traditional Chinese Medicine Hospital
    - Contatto:
      
      Yong Gu, M.D.
      
      Numero di telefono: 15521280288
- Hunan
  - Changsha, Hunan, Cina
    - Reclutamento
    - The First Hospital of Changsha
    - Contatto:
      
      Xu Peng, M.D。
      
      Numero di telefono: 15802507292
  - Hengyang, Hunan, Cina
    - Reclutamento
    - The Second Hospital University of South China
    - Contatto:
      
      Yanhong Hu, M.D.
      
      Numero di telefono: 13265004191
  - Yueyang, Hunan, Cina
    - Reclutamento
    - Yueyang People's Hospital
    - Contatto:
      
      Yuan Zhou, M.D.
      
      Numero di telefono: 15107309796
- Inner Mongolia
  - Baotou, Inner Mongolia, Cina
    - Reclutamento
    - Sinopharm North Hospital
    - Contatto:
      
      Lifei Xing, M.D
      
      Numero di telefono: 15354919958
  - Hohhot, Inner Mongolia, Cina
    - Reclutamento
    - The Affiliated Hospital of Inner Mongolia Medical University
    - Contatto:
      
      Lihua Sun, M.D.
      
      Numero di telefono: 18686292585
- Jiangxi
  - Ganzhou, Jiangxi, Cina
    - Reclutamento
    - Ganzhou City People's Hospital
    - Contatto:
      
      Zhaohui Lai
      
      Numero di telefono: 13879729792
- Zhejiang
  - Wenzhou, Zhejiang, Cina
    - Reclutamento
    - Second Affiliated Hospital of Wenzhou Medical University
    - Contatto:
      
      Saijun Zhou, M.D.
      
      Numero di telefono: 13857746659

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione di probabilità

Popolazione di studio

Patients who are treated with mechanical thrombectomy with acute anterior circulation large vessel occlusion. ≥18 years of age, within 24 hours of onset. Expected survival >3 months. NIHSS score ≥ 6 at onset of illness.

Descrizione

Inclusion Criteria:

Age ≥18 years.
Within 24 hours of onset. Meet the criteria for diagnosis of acute ischemic stroke in the "China Acute Ischemic Stroke Diagnosis and Treatment Guidelines 2018".
Meet the indications for mechanical thrombectomy in the "Chinese Guidelines for Early Endovascular Interventions in Acute Ischemic Stroke 2022".
Treated with mechanical thrombectomy.
NIHSS score ≥ 6 at onset of illness.
Sign an informed notice.

Exclusion Criteria:

Allergy to drug ingredients. Women who are pregnant or breastfeeding. Life expectancy of less than 3 months due to other non-ischemic stroke diseases such as malignancy, severe liver or renal failure.

Have participated in other interventional clinical studies (affecting the outcome of this cohort study).

Participants who were judged by the investigator to be unsuitable for participation in this study.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Modelli osservazionali: COHORT
Prospettive temporali: PROSPECTIVE

Numero di gruppi/coorti

Coorti e interventi

Gruppo / Coorte
Stress Ulcer Prophylaxis Subjects are on stress ulcer medications including PPIs, H2RBs, and mucosal protectors at 24 h of admission.
Control Group Subjects are not on stress ulcer medications including PPIs, H2RBs, and mucosal protectors at 24 h of admission.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
90-day mortality after onset Lasso di tempo: 90-day after onset	Proportion of enrolled patients who died 90 days after onset of disease.	90-day after onset
Incidence of stroke-associated pneumonia Lasso di tempo: within 7-day of onset	Incidence of non-mechanically ventilated stroke patients with new pneumonia within 7-day of onset	within 7-day of onset

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Incidence of clinically significant bleeding Lasso di tempo: within 7-day of onset	One of the following 4 symptoms occurs within 24 hours of bleeding from a stress ulcer (in the absence of other causes):1. A decrease of ≥ 20 mmHg in any one of systolic, diastolic and mean arterial pressure. 2.Initiation of blood pressure boosters or 20% increase in medication dose.3. Decreased hemoglobin ≥ 2 g/d(（1.24 mmol/l). 4.Infusion of erythrocytes ≥ 2 U.	within 7-day of onset
Incidence of stress ulcer bleeding Lasso di tempo: 7-day after onset	Coffee-like residue/black stool/blood in stool within 7-day after onset and more than 2 consecutive positive fecal/gastric fluid occult blood	7-day after onset
Incidence of unfavorable functional prognosis at 90 days after onset Lasso di tempo: 90-day after onset	Incidence of unfavorable functional prognosis at 90 days after onset	90-day after onset
90-day mRS score change Lasso di tempo: 90-day after onset	Modified Rankin Scale score change within 90 days after onset in patients who were eligible for inclusion criteria	90-day after onset
Incidence of early neurological deterioration Lasso di tempo: within 72 hours after onset	Increased score of National Institutes of Health Stroke Scale within 72h after onset ≥ 4	within 72 hours after onset
1-year post-onset mortality Lasso di tempo: 1 year after onset	Mortality at 1 year after onset in patients who were eligible for inclusion criteria	1 year after onset
Incidence of adverse related events such as pneumonia or myocardial ischemia 1 year after onset Lasso di tempo: 1 year after onset	Incidence of adverse related events such as pneumonia or myocardial ischemia 1 year after onset in patients who were eligible for inclusion criteria	1 year after onset

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Nanfang Hospital, Southern Medical University

Collaboratori

Second Affiliated Hospital of Guangxi Medical University

Guangdong Provincial Hospital of Traditional Chinese Medicine

Fujian Medical University Union Hospital

Second Affiliated Hospital of Wenzhou Medical University

Dongguan People's Hospital

Huizhou Municipal Central Hospital

The Affiliated Hospital of Inner Mongolia Medical University

Hainan People's Hospital

Huadu District People's Hospital of Guangzhou

Guangzhou Medical University

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

Kashgar 1st People's Hospital

The Second Hospital University of South China

Haikou People's Hospital

Ganzhou City People's Hospital

Sinopharm North Hospital

Hainan Traditional Chinese Medicine Hospital

Yueyang People's Hospital

Heyuan Shenhe People's Hospital

Investigatori

Investigatore principale: Suyue Pan, Department of Neurology, Nanfang Hospital,Southern Medical University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 maggio 2023

Completamento primario (Effettivo)

1 agosto 2026

Completamento dello studio (Stimato)

1 maggio 2027

Date di iscrizione allo studio

Primo inviato

26 aprile 2023

Primo inviato che soddisfa i criteri di controllo qualità