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Clinical trial of Batroxobin injection in the treatment of progressing stroke

Clinical trial of Batroxobin injection in the treatment of progressing stroke

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OCH-14004480
Enrollment
Unknown
Registered
2014-04-08
Start date
2014-05-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Progressing Stroke

Interventions

test group:Standardized treatment protocols of Ischemic stroke and Batroxobin Injection

Sponsors

The First Affiliated Hospital of Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Consecutive patients with admitted to the hospitals with acute ischemic infarction within 24 hours of symptoms onset, and diagnosed as progressing stroke by the Scandinavian Stroke Scale (SSS) within 72 h of hospital admission; 2. Aged 18 years and more; 3. Patients with clear consciousness; 4. Modified Rankin Scale (mRS) score < 2; 5. Patients or their legal representative has signed the "informed consent".

Exclusion criteria

Exclusion criteria: 1. Hemorrhagic stroke; 2. Transient ischemic attack (TIA); 3. Bleeding tendency caused by blood diseases, hemorrhage of digestive tract and so on; 4. Uncontrolled hypertension (systolic blood pressure = 200mmHg or diastolic blood pressure = 110mmHg) should be excluded; 5. With severe liver dysfunction (glutamic pyruvic transaminase or glutamic oxalacetic transaminase is higher than the normal value of 1.5 times) or renal dysfunction ((urea or creatinine is greater than the normal range above 10%)); 6. Patients with atrial fibrillation or serious heart diseases; 7. Patients applied or are applied anticoagulant drug, thrombolytic drug or Fibrinogen depleting agents within two weeks; 8. Plan to major surgery, carotid endarterectomy or stenting angioplasty; 9. Patients with malignant tumor or intracranial tumor; 10. Pregnant women, pregnancy planners or lactation period women; 11. Patients who are known to have an allergy to Batroxobin Injection; 12. Currently participating in the clinical research of other drugs.

Design outcomes

Primary

MeasureTime frame
National Institutes of Health Stroke Scale (NIHSS);Barthel Index;Modified Rankin Scal;

Countries

China

Contacts

Public ContactHong-Lin Feng

Department of Neurology, The First Affiliated Hospital of Harbin Medical University

fenghonglin5678@sina.com+86 0451 85555666

Outcome results

None listed

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