Oral Hygiene and Prophylactic Antibiotics to Prevent Intracerebral Hemorrhage Associated Pneumonia

Korábbi kezelés

• Patients scheduled for surgical intervention before the first administration, including but not limited to hematoma evacuation (including minimally invasive and conventional surgery), decompressive craniectomy, hematoma aspiration, and external ventricular drainage.

Más betegség

• Secondary intracerebral hemorrhage, such as that resulting from cerebral aneurysms, cerebral arteriovenous malformations, brain tumors, cerebral venous system thrombosis, antithrombotic therapy (antiplatelet, anticoagulant therapy, etc.), hemorrhagic transformation after cerebral infarction, hematological diseases, etc.
• Other severe diseases that lead to an expected lifespan of less than 1 year.
• Patients unable to understand the research procedures and/or complete follow-up due to mental illness, cognitive impairment, emotional disorders, etc.
• Known allergy to cephalosporins, penicillins, or chlorhexidine compound mouthwash.
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Laborértékek

• A history of severe cardiovascular disease, meeting any of the following: 1) Heart failure (New York Heart Association functional class ≥ III); 2) Unstable angina within 3 months; 3) Any supraventricular or ventricular arrhythmia requiring treatment; 4) Prolonged QTc interval considered clinically significant by the investigator (reference range: > 450ms for men, > 470ms for women) (Note: QTc interval must be calculated according to Fridericia's formula); 5) Complete atrioventricular block and left or right bundle branch block requiring treatment; 6) Acute myocardial infarction or interventional treatment within 1 month; high-risk patients with chronic arrhythmia, such as sick sinus syndrome, second or third-degree atrioventricular block, bradycardia-related syncope without pacemaker installation, etc.
• Diagnosed with severe active liver disease, such as acute hepatitis, chronic active hepatitis, liver cirrhosis, etc.; or ALT or AST > 3 times the upper limit of normal.
• Severe renal insufficiency: such as patients undergoing dialysis, or diagnosed with severe active kidney disease, etc., or creatinine clearance rate < 50 mL/min.

Egyéb

• The patient's clinical symptoms and signs suggest signs of brain herniation, such as progressive decline in consciousness level, weakened or absent pupillary light reflex.
• Obvious signs of pneumonia already exist, such as fever, persistent cough or yellow purulent sputum, and imaging examinations (chest X-ray or chest CT) suggest signs of pneumonia; two consecutive measurements of body temperature ≥ 37.5℃, or one measurement of body temperature ≥ 38.0℃.
• Pregnant or lactating women.
• Participation in other clinical studies within 3 months or currently participating in other clinical studies.

• Age 18-80 years old;
• Spontaneous intracerebral hemorrhage;
• Supratentorial intracerebral hemorrhage (ICH);
• Hematoma volume < 30 ml (calculated by ABC/2 method);
• Glasgow Coma Scale score ≥ 9 at randomization;
• Time from onset to randomization ≤ 72 hours;
• Spontaneous intracerebral hemorrhage-associated pneumonia score (ICH-APS) ≥ 8;
• Informed consent from the patient and/or their family.