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Multicentric, Randomized,Controlled and Comparative Study to Evaluate the Efficacy of Two Treatment Schemes With Antivipmyn ® for the Treatment of Snake Bite Envenomation
The purpose of this study is to compare whether a same total dose given up front as a single dose is more effective and as safe as the same dose given as a fractioned dose. Evaluate the Utility of the the Dry Tube Test Evaluating its Correlation with Coagulation Test Results (fibrinogen, platelets, INR, PT and PTT). Explore the Evolution of some Serum Markers (CK, DHL, metalloproteinase), Amount of Venom and Antivenom Levels and the Progression of Local Lesions.
Details
| Lead sponsor | Instituto Bioclon S.A. de C.V. |
|---|---|
| Phase | Phase 4 |
| Status | TERMINATED |
| Enrolment | 10 |
| Start date | 2008-01 |
| Completion | 2009-03 |
Conditions
- Snake Bite
Interventions
- A
- Antivipmyn ®
Primary outcomes
- Resolution of systemic signs and symptoms of snake bite envenomation expressed as % of patients requiring additional antivenom and % of patients that are stable — 12 hours after initial treatment
Countries
Mexico