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Związek między profilaktycznym stosowaniem leków przeciwwrzodowych stresowych a wynikami klinicznymi u pacjentów z ostrą trombektomią przedniego krążenia

2 listopada 2026 zaktualizowane przez: Nanfang Hospital, Southern Medical University

Związek profilaktycznego stosowania leków przeciwwrzodowych stresowych i wyników klinicznych u pacjentów z ostrą trombektomią przedniego krążenia: prospektywne, wieloośrodkowe, obserwacyjne badanie kohortowe

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Ostry udar niedokrwienny

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

2592

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Nazwa: Suyue Pan, M.D., Ph.D.
Numer telefonu: 13556184981
E-mail: pansuyue@smu.edu.cn

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka prawdopodobieństwa

Badana populacja

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.

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Modele obserwacyjne: COHORT
Perspektywy czasowe: PROSPECTIVE

Liczba grup / kohort

Kohorty i interwencje

Grupa / Kohorta
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
90-day mortality after onset Ramy czasowe: 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 Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku	Opis środka	Ramy czasowe
Incidence of clinically significant bleeding Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 90-day after onset	Incidence of unfavorable functional prognosis at 90 days after onset	90-day after onset
90-day mRS score change Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Nanfang Hospital, Southern Medical University

Współpracownicy

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

Śledczy

Główny śledczy: Suyue Pan, Department of Neurology, Nanfang Hospital,Southern Medical University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 maja 2023

Zakończenie podstawowe (Rzeczywisty)

1 sierpnia 2026

Ukończenie studiów (Szacowany)

1 maja 2027

Daty rejestracji na studia

Pierwszy przesłany

26 kwietnia 2023

Pierwszy przesłany, który spełnia kryteria kontroli jakości