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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00639951
Recruitment Status : Terminated (Administrative reasons)
First Posted : March 20, 2008
Last Update Posted : July 20, 2016
Information provided by (Responsible Party):
Instituto Bioclon S.A. de C.V.

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.

Condition or disease Intervention/treatment Phase
Snake Bite Biological: A Biological: Antivipmyn ® Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : March 2009

Arm Intervention/treatment
Active Comparator: A Normal dose Group
20 vials up front in a Single Dose of Antivipmyn in 500 ml of solution IV, administered in 60 minutes. After 12 hours, it has to be perfomed a clinical evaluation of the patient. Each patient is going to have clinical studies of coagulation time and also the fibrinogen measures, this at 2, 4, 6, 8, 10, 12, 48, 72, 96 hours.All patients who have received at least one dose of medication study will be contacted by telephone to investigate the presence of symptoms suggestive of continuing with effect snake venom, or the presence of an adverse event, or any signs or symptoms indicating the presence of a hypersensitivity response to Antivipmyn® including serum sickness. If symptoms suggestive of an adverse event were discovered, the patient will referred for appropriate treatment.
Biological: A
20 vials up front in a Single Dose of Antivipmyn
Other Name: Crotalinae (pit viper) equine immune F(ab)2

Placebo Comparator: B Placebo Group
20 vials fractionated into 4 doses of 5 vials each of Antivipmyn ®. The treatment schedule for each subject is a dose of 5 vials Antivipmyn® every 2 hours to complete 20 vials, the total duration is 6 hours of the treatment. Each dose IV shall apply in physiological solution 250ml, and finish its application in 15 minutes. For pediatric patients the volume administered should not exceed the recommended fluid volume according to your body weight. After the assessment at 12 hours, it can be administered at the discretion of more antivenom attending by the physician.
Biological: Antivipmyn ®
20 vials fractionated into 4 doses of 5 vials each of Antivipmyn ®
Other Name: Crotalinae (pit viper) equine immune F(ab)2

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. Evaluate Venom and Antivenom Levels with the other parameters [ Time Frame: baseline, 2 hours after initial treatment and after each extra dose of Antivenom ]
  3. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00639951

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Hermosillo Site
Sonora, Hermosillo, Mexico
Nayarit Site
Tepic, Nayarit, Mexico, 63000
Hospital Universitario de la UANL "Dr. José Eleuterio González"
Monterrey, NL, Mexico, 64460
Ciudad Valles Site
Ciudad Valles, San Luis Potosi, Mexico
Tempoal Site
Tempoal, Veracruz, Mexico, 92061
Sponsors and Collaborators
Instituto Bioclon S.A. de C.V.
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Study Director: Walter García, MD Instituto Bioclon
Study Chair: Anabel Loza, MD Instituto Bioclon
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Responsible Party: Instituto Bioclon S.A. de C.V. Identifier: NCT00639951    
Other Study ID Numbers: YA-07/01
First Posted: March 20, 2008    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Not yet decided
Keywords provided by Instituto Bioclon S.A. de C.V.:
Snake Bite
Antivenin Treatment
Additional relevant MeSH terms:
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Snake Bites
Bites and Stings
Chemically-Induced Disorders
Wounds and Injuries