Association of Prophylactic Use of Stress Ulcer Drugs and Clinical Outcomes in Patients With Acute Anterior Circulation Thrombectomy

Association of Prophylactic Use of Stress Ulcer Drugs and Clinical Outcomes in Patients With Acute Anterior Circulation Thrombectomy: a Prospective, Multicenter, Observational Cohort Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Ischemic Stroke

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 2592

Contacts and Locations

• Study Contact: Name: Suyue Pan, M.D., Ph.D.; Phone Number: 13556184981; Email: pansuyue@smu.edu.cn

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
90-day mortality after onset	Proportion of enrolled patients who died 90 days after onset of disease.	90-day after onset
Incidence of stroke-associated pneumonia	Incidence of non-mechanically ventilated stroke patients with new pneumonia within 7-day of onset	within 7-day of onset

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of clinically significant bleeding	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	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	Incidence of unfavorable functional prognosis at 90 days after onset	90-day after onset
90-day mRS score change	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	Increased score of National Institutes of Health Stroke Scale within 72h after onset ≥ 4	within 72 hours after onset
1-year post-onset mortality	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	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

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University
• Collaborators: 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; 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; Dongguan donghua hospital; Ganzhou City People's Hospital; The Fourth Affiliated Hospital of Guangzhou Medical University; Sinopharm North Hospital; Heyuan people's Hospital; Hainan Traditional Chinese Medicine Hospital; Yueyang People's Hospital
• Investigators: Principal Investigator: Suyue Pan, Department of Neurology, Nanfang Hospital,Southern Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): January 1, 2027
• Study Completion (Anticipated): January 1, 2027

Study Registration Dates

• First Submitted: April 26, 2023
• First Submitted That Met QC Criteria: April 26, 2023
• First Posted (Estimate): May 5, 2023

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Acute Ischemic Stroke; Mechanical Thrombectomy; Stress Ulcer Bleeding
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: NFEC-2023-040

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No