Study to Evaluate the Efficacy of Two Treatment Schemes With Antivipmyn ® for the Treatment of Snake Bite Envenomation

Phase 4TerminatedNCT00639951

Instituto Bioclon S.A. de C.V.10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Snake Bite

Interventions

ABIOLOGICAL

20 vials up front in a Single Dose of Antivipmyn

Antivipmyn ®BIOLOGICAL

20 vials fractionated into 4 doses of 5 vials each of Antivipmyn ®

Eligibility

Sex: ALLMin age: 6 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men and women 6 to 65 years of age * Presenting for emergency treatment of snake bite * Requiring treatment with antivenom * Informed consent document read and signed by patient (or parent/legal guardian) * Participation within the last month on any clinical trial * Arrival to Hospital within 24 hours after the snake bite Exclusion Criteria: * Allergy to horse serum * Underlying medical conditions that significantly alter coagulation (oral anticoagulants, vitamin K deficiency, hepatic disease) * Use of AINE 48 hours previously * Use of any antivenom 2 weeks previously * Pregnancy or breast-feeding women

Locations (5)

Hermosillo Site

Sonora, Hermosillo, Mexico

Nayarit Site

Tepic, Nayarit, Mexico

Hospital Universitario de la UANL "Dr. José Eleuterio González"

Monterrey, Nuevo León, Mexico

Ciudad Valles Site

Ciudad Valles, San Luis Potosí, Mexico

Outcomes

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

Time frame: 12 hours after initial treatment

Secondary Outcomes

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

Evaluate Venom and Antivenom Levels with the other parameters

Time frame: baseline, 2 hours after initial treatment and after each extra dose of Antivenom

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

Data from ClinicalTrials.gov

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