Clinical trial NCT00639951: Study to Evaluate the Efficacy of Two Treatment Schemes With Antivipmyn ® for the Treatment of Snake Bite Envenomation
Official title: Multicentric, Randomized,Controlled and Comparative Study to Evaluate the Efficacy of Two Treatment Schemes With Antivipmyn ® for the Treatment of Snake Bite Envenomation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Snake Bite
Keywords: Snake Bite
Antivenin Treatment
Lead sponsor: Instituto Bioclon S.A. de C.V.
Sponsor class: INDUSTRY
First posted: 2008-03-20
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Resolution of systemic signs and symptoms of snake bite envenomation expressed as % of patients requiring additional antivenom and % of patients that are stable
timeFrame: 12 hours after initial treatment
Secondary outcomes:
measure: Evaluate the correlation between Dry Tube Test and Coagulation Test (PT, INR, PTT, platelets and fibrinogen)
timeFrame: baseline, 2,4,6 hours and after each extra dose of Antivenom
measure: Evaluate Venom and Antivenom Levels with the other parameters
timeFrame: baseline, 2 hours after initial treatment and after each extra dose of Antivenom
measure: Evaluate the possible relation of the serum markers (LDH, CPK, metalloproteinases)and local damage evolution.
timeFrame: baseline, 2, 4,6 and after each extra dose of Antivenom
Other outcomes:
Locations:
city: Sonora
country: Mexico
facility: Hermosillo Site
state: Hermosillo
city: Tepic
country: Mexico
facility: Nayarit Site
state: Nayarit
city: Monterrey
country: Mexico
facility: Hospital Universitario de la UANL "Dr. José Eleuterio González"
state: NL
city: Ciudad Valles
country: Mexico
facility: Ciudad Valles Site
state: San Luis Potosi
city: Tempoal
country: Mexico
facility: Tempoal Site
state: Veracruz
Study officials:
affiliation: Instituto Bioclon
name: Walter García, MD
role: STUDY_DIRECTOR
affiliation: Instituto Bioclon
name: Anabel Loza, MD
role: STUDY_CHAIR
References: