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급성 전방순환 혈전절제술 환자에서 스트레스성 궤양 약물의 예방적 사용과 임상적 결과의 연관성

2026년 11월 2일 업데이트: Nanfang Hospital, Southern Medical University

급성 전방 순환 혈전 절제술 환자에서 스트레스성 궤양 약물의 예방적 사용과 임상 결과의 연관성: 전향적, 다기관, 관찰적 코호트 연구

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.

연구 개요

상태

모병

정황

급성 허혈성 뇌졸중

상세 설명

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.

연구 유형

관찰

등록 (추정된)

2592

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Suyue Pan, M.D., Ph.D.
전화번호: 13556184981
이메일: pansuyue@smu.edu.cn

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

관찰 모델: COHORT
시간 관점: PROSPECTIVE

그룹/코호트 수

코호트 및 개입

그룹/코호트
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
90-day mortality after onset 기간: 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 기간: 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

2차 결과 측정

결과 측정	측정값 설명	기간
Incidence of clinically significant bleeding 기간: 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 기간: 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 기간: 90-day after onset	Incidence of unfavorable functional prognosis at 90 days after onset	90-day after onset
90-day mRS score change 기간: 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 기간: 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 기간: 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 기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Nanfang Hospital, Southern Medical University

협력자

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

수사관

수석 연구원: Suyue Pan, Department of Neurology, Nanfang Hospital,Southern Medical University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 5월 1일

기본 완료 (실제)

2026년 8월 1일

연구 완료 (추정된)

2027년 5월 1일

연구 등록 날짜

최초 제출

2023년 4월 26일

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