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

Official title

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

Overview

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.

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.

Primary outcome measures

• 90-day mortality after onset [Time frame: 90-day after onset]
• Incidence of stroke-associated pneumonia [Time frame: within 7-day of onset]

Secondary outcome measures (7)

• Incidence of clinically significant bleeding [Time frame: within 7-day of onset]
• Incidence of stress ulcer bleeding [Time frame: 7-day after onset]
• Incidence of unfavorable functional prognosis at 90 days after onset [Time frame: 90-day after onset]
• 90-day mRS score change [Time frame: 90-day after onset]
• Incidence of early neurological deterioration [Time frame: within 72 hours after onset]
• 1-year post-onset mortality [Time frame: 1 year after onset]
• Incidence of adverse related events such as pneumonia or myocardial ischemia 1 year after onset [Time frame: 1 year after onset]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 19 centers

• Fujian Medical University Union Hospital — Fuzhou
• Dongguan donghua hospital — Dongguan
• Dongguan People's Hospital — Dongguan
• Guangdong Provincial Hospital of Traditional Chinese Medicine — Guangzhou
• Huadu District People's Hospital of Guangzhou — Guangzhou
• Nanfang Hospital of Southern Medical University — Guangzhou
• The Fourth Affiliated Hospital of Guangzhou Medical University — Guangzhou
• Heyuan people's Hospital — Heyuan
• … and 11 more centers

Identifiers

NCT: NCT05845372 · NFEC-2023-040

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗