Asociace profylaktického použití léků na stresový vřed a klinických výsledků u pacientů s akutní trombektomií předního oběhu
Asociace profylaktického použití léků na stresový vřed a klinických výsledků u pacientů s akutní trombektomií předního oběhu: prospektivní, multicentrická, observační kohortová studie
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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 studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Suyue Pan, M.D., Ph.D.
- Telefonní číslo: 13556184981
- E-mail: pansuyue@smu.edu.cn
Studijní místa
-
-
Fujian
-
Fuzhou, Fujian, Čína
- Nábor
- Fujian Medical University Union Hospital
-
Kontakt:
- Shenggen Chen, M.D.
- Telefonní číslo: 13459480275
-
-
Guangdong
-
Dongguan, Guangdong, Čína
- Nábor
- Dongguan People's Hospital
-
Kontakt:
- Zhu Shi, M.D.
- Telefonní číslo: 13669825459
-
Dongguan, Guangdong, Čína
- Nábor
- Dongguan donghua hospital
-
Kontakt:
- Lingyu Sun
- Telefonní číslo: 13829203368
-
Guangzhou, Guangdong, Čína
- Nábor
- Nanfang Hospital of Southern Medical University
-
Kontakt:
- Suyue Pan
- Telefonní číslo: 13556184981
-
Guangzhou, Guangdong, Čína
- Nábor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
-
Kontakt:
- Lixin Wang, M.D.
- Telefonní číslo: 13922793886
-
Guangzhou, Guangdong, Čína
- Nábor
- Huadu District People's Hospital of Guangzhou
-
Kontakt:
- Guangning Li, M.D.
- Telefonní číslo: 13926239656
-
Guangzhou, Guangdong, Čína
- Nábor
- The Fourth Affiliated Hospital of Guangzhou Medical University
-
Kontakt:
- Wangchi Luo, M.D.
- Telefonní číslo: 13710895142
-
Heyuan, Guangdong, Čína
- Nábor
- Heyuan people's Hospital
-
Kontakt:
- Minzhen Zhu
- Telefonní číslo: 15007622318
-
Huizhou, Guangdong, Čína
- Nábor
- Huizhou Municipal Central Hospital
-
Kontakt:
- Lizhi Wang, M.D.
- Telefonní číslo: 13802872076
-
-
Hainan
-
Haikou, Hainan, Čína
- Nábor
- Hainan Provincial People's Hospital
-
Kontakt:
- Fan Zhang, M.D.
- Telefonní číslo: 17389897580
-
Haikou, Hainan, Čína
- Nábor
- Haikou People's Hospital
-
Kontakt:
- Guoshuai Yang, M.D.
- Telefonní číslo: 13876006248
-
Haikou, Hainan, Čína
- Nábor
- Hainan Traditional Chinese Medicine Hospital
-
Kontakt:
- Yong Gu, M.D.
- Telefonní číslo: 15521280288
-
-
Hunan
-
Changsha, Hunan, Čína
- Nábor
- The First Hospital of Changsha
-
Kontakt:
- Xu Peng, M.D。
- Telefonní číslo: 15802507292
-
Hengyang, Hunan, Čína
- Nábor
- The Second Hospital University of South China
-
Kontakt:
- Yanhong Hu, M.D.
- Telefonní číslo: 13265004191
-
Yueyang, Hunan, Čína
- Nábor
- Yueyang People's Hospital
-
Kontakt:
- Yuan Zhou, M.D.
- Telefonní číslo: 15107309796
-
-
Inner Mongolia
-
Baotou, Inner Mongolia, Čína
- Nábor
- Sinopharm North Hospital
-
Kontakt:
- Lifei Xing, M.D
- Telefonní číslo: 15354919958
-
Hohhot, Inner Mongolia, Čína
- Nábor
- The Affiliated Hospital of Inner Mongolia Medical University
-
Kontakt:
- Lihua Sun, M.D.
- Telefonní číslo: 18686292585
-
-
Jiangxi
-
Ganzhou, Jiangxi, Čína
- Nábor
- Ganzhou City People's Hospital
-
Kontakt:
- Zhaohui Lai
- Telefonní číslo: 13879729792
-
-
Zhejiang
-
Wenzhou, Zhejiang, Čína
- Nábor
- Second Affiliated Hospital of Wenzhou Medical University
-
Kontakt:
- Saijun Zhou, M.D.
- Telefonní číslo: 13857746659
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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.
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / 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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
90-day mortality after onset
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Incidence of clinically significant bleeding
Časové okno: 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
Časové okno: 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
Časové okno: 90-day after onset
|
Incidence of unfavorable functional prognosis at 90 days after onset |
90-day after onset
|
|
90-day mRS score change
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Suyue Pan, Department of Neurology, Nanfang Hospital,Southern Medical University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- NFEC-2023-040
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .