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Associatie van profylactisch gebruik van stresszweren en klinische resultaten bij patiënten met acute anterieure circulatietrombectomie

2 november 2026 bijgewerkt door: Nanfang Hospital, Southern Medical University

Associatie van profylactisch gebruik van stressulcusgeneesmiddelen en klinische resultaten bij patiënten met acute anterieure circulatietrombectomie: een prospectieve, multicenter, observationele cohortstudie

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.

Studie Overzicht

Toestand

Werving

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

2592

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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.

Beschrijving

Inclusion Criteria:

  1. Age ≥18 years.
  2. 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".
  3. Meet the indications for mechanical thrombectomy in the "Chinese Guidelines for Early Endovascular Interventions in Acute Ischemic Stroke 2022".
  4. Treated with mechanical thrombectomy.
  5. NIHSS score ≥ 6 at onset of illness.
  6. 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
90-day mortality after onset
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of clinically significant bleeding
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 90-day after onset

Incidence of unfavorable functional prognosis at 90 days after onset
90-day after onset
90-day mRS score change
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Nanfang Hospital, Southern Medical University

Medewerkers

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

Onderzoekers

  • Hoofdonderzoeker: Suyue Pan, Department of Neurology, Nanfang Hospital,Southern Medical University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 mei 2023

Primaire voltooiing (Werkelijk)

1 augustus 2026

Studie voltooiing (Geschat)

1 mei 2027

Studieregistratiedata

Eerst ingediend

26 april 2023

Eerst ingediend dat voldeed aan de QC-criteria

26 april 2023

Eerst geplaatst (Werkelijk)

6 mei 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NFEC-2023-040

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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