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.
Primary Outcome Measures:
- Resolution of systemic signs and symptoms of snake bite envenomation expressed as % of patients requiring additional antivenom and % of patients that are stable [ Time Frame: 12 hours after initial treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Evaluate the correlation between Dry Tube Test and Coagulation Test (PT, INR, PTT, platelets and fibrinogen) [ Time Frame: baseline, 2,4,6 hours and after each extra dose of Antivenom ] [ Designated as safety issue: No ]
- Evaluate Venom and Antivenom Levels with the other parameters [ Time Frame: baseline, 2 hours after initial treatment and after each extra dose of Antivenom ] [ Designated as safety issue: Yes ]
- Evaluate the possible relation of the serum markers (LDH, CPK, metalloproteinases)and local damage evolution. [ Time Frame: baseline, 2, 4,6 and after each extra dose of Antivenom ] [ Designated as safety issue: No ]
| Estimated Enrollment: |
80 |
| Study Start Date: |
April 2008 |
| Estimated Study Completion Date: |
August 2009 |
| Estimated Primary Completion Date: |
February 2009 (Final data collection date for primary outcome measure) |
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A: Experimental
20 vials up front in a Single Dose of Antivipmyn
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Biological: Antivipmyn ®
20 vials up front in a Single Dose of Antivipmyn
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B: Experimental
20 vials fractionated into 4 doses of 5 vials each of Antivipmyn ®
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Biological: Antivipmyn ®
20 vials fractionated into 4 doses of 5 vials each of Antivipmyn ®
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Snake bite Envenomation is a Public Health Problem especially for tropical and subtropical countries. The WHO estimates 40 000 annual deaths in the world for this cause. In México the Ministry of Health estimated 3 882 cases on 2005, being the age of 15-44 the most affected. There are not official numbers of mortality, although the thought is that there are few cases of death, most of them related with a delay on treatment.
There are a broad variety of clinical presentations depending on many factors such as species, snake bite variability or patient conditions. Proteolytic action of venom produces amines and vasoactive peptides such as bradykinin, histamine and serotonin which cause capillary lesions with anticoagulant effects. Coagulopathy is one of the most important systemic consequences. The Dry Tube Test has been proposed as an indirect test to evaluate coagulopathy related to this pathology.
Purpose
