Sudden Deafness
Conditions
Interventions
The observation group treated with batroxobin:None
Sponsors
Peking University People’s hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who are considered by the investigator to meet the approved indications of Batroxobin Injection, i.e. those who need to improve peripheral circulatory and microcirculatory dysfunction (e.g. sudden deafness)(Diagnosed based on the guidelines for the diagnosis and treatment of Sudden Deafness); 2. Subjects who voluntarily sign the informed consent form; 3. Subjects who provide valid legal identity proof.
Exclusion criteria
Exclusion criteria: 1. Patients who are considered to meet any contraindication of Batroxobin Injection:(1) Patients with active bleeding or at risk of bleeding in vital organs (suspicion of intracranial hemorrhage,orarachnoid hemorrhage or hemorrhagic stroke, hematologic diseases, during menstruation, digestive tract ulcers or bleeding, digestive tract tumors, diverticulitis of THE9digestive tract, colitis, subacute bacterial endocarditis, rupture of the papillary muscle, ventricular septal perforation, hematia, hemoptysis, severe hypertension with bleeding tendency, severe diabetic patients with retinal bleeding, etc.); (2) Patients who had recently undergone an operation.(24 hours postoperatively, and patients may have bleeding or difficulty in hemostasis,judged by the investigator ); (3) Patients with pre-medication fibogen = 180 mmHg, diastolic blood pressure >= 100 mmHg), and patients unsuitable for this drug, judged by the investigator; (5) Patients with severe hepatic dysfunction (alanine aminotransferase (ALT), aspartate aminransferase (AST) > 3 times the upper limit of normal), and patients unsuitable for this drug, judged by the investigator; (6) Patients with severe renal dysfunction (blood creatinine > 2 times the upper limit of normal), and patients unsuitable for this drug, judged by the investigator; (7) Patients with severe atrial fibrillation, or severe heart failure, cardiogenic shock, and multi-organ failure; 2. Patients who have allergy to any component of Batroxobin Injection; 3. Patients who are pregnant or lactating at the time of screening for this study; 4. Patients who have other conditions that the investigator considers unsuitable for participation this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood routine;Blood biochemistry;Coagulation function test;Urine routine;Stool routine;Adverse Event; | — |
Countries
China
Contacts
Public ContactYu Lisheng
Peking University People’s hospital
Outcome results
None listed