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Observational study on post-marketing safety of Batroxobin injection in patients with acute cerebral infarction (acute ischemic stroke)

Observational study on post-marketing safety of Batroxobin injection in patients with acute cerebral infarction (acute ischemic stroke)

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600117253
Enrollment
Unknown
Registered
2026-01-21
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute cerebral infarction (acute ischemic stroke)

Interventions

Batroxobin group:None

Sponsors

Beijing Friendship Hospital, Capital Medical University
Lead Sponsor

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. patients with acute cerebral infarction (acute ischemic stroke)(Diagnosed based on the guidelines for the diagnosis and treatment of acute ischemic stroke); 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 with a history of amyloidosis disease; 4. Patients who are pregnant or lactating at the time of screening for this study; 5.Patients who have other conditions that the investigator considers unsuitable for participation this trial.

Design outcomes

Primary

MeasureTime frame
Blood routine;blood biochemistry;Coagulation function ;urine routine;Stool routine;Adverse Event;

Countries

China

Contacts

Public ContactZhang Yongbo

Beijing Friendship Hospital, Capital Medical University

ybzhangcn@sina.com+86 10 6313 8628

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026