Study to Evaluate the Efficacy of Two Treatment Schemes With Antivipmyn ® for the Treatment of Snake Bite Envenomation
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Snake Bite |
Biological: Antivipmyn ® |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
- 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 ]
- 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: | July 2013 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
20 vials up front in a Single Dose of Antivipmyn
|
Biological: Antivipmyn ®
20 vials up front in a Single Dose of Antivipmyn
Other Name: Crotalinae (pit viper) equine immune F(ab)2
|
|
Experimental: B
20 vials fractionated into 4 doses of 5 vials each of Antivipmyn ®
|
Biological: Antivipmyn ®
20 vials fractionated into 4 doses of 5 vials each of Antivipmyn ®
Other Name: Crotalinae (pit viper) equine immune F(ab)2
|
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| Ages Eligible for Study: | 6 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: Walter Garcia Ubbelohde, MD | 54883700 ext 3785 | wgarcia@silanes.com.mx |
| Contact: Anabel Loza, MD | 54883700 ext 3823 | aloza@silanes.com.mx |
| Mexico | |
| Hermosillo Site | Recruiting |
| Sonora, Hermosillo, Mexico | |
| Nayarit Site | Suspended |
| Tepic, Nayarit, Mexico, 63000 | |
| Hospital Universitario de la UANL "Dr. José Eleuterio González" | Recruiting |
| Monterrey, NL, Mexico, 64460 | |
| Ciudad Valles Site | Recruiting |
| Ciudad Valles, San Luis Potosi, Mexico | |
| Tampico Site | Withdrawn |
| Tampico, Tamaulipas, Mexico, 89130 | |
| Tempoal Site | Suspended |
| Tempoal, Veracruz, Mexico, 92061 | |
| Study Director: | Walter García, MD | Instituto Bioclon |
| Study Chair: | Anabel Loza, MD | Instituto Bioclon |
More Information
No publications provided
| Responsible Party: | Instituto Bioclon S.A. de C.V. |
| ClinicalTrials.gov Identifier: | NCT00639951 History of Changes |
| Other Study ID Numbers: | YA-07/01 |
| Study First Received: | March 13, 2008 |
| Last Updated: | May 14, 2012 |
| Health Authority: | Mexico: Ministry of Health Mexico: Federal Commission for Sanitary Risks Protection |
Keywords provided by Instituto Bioclon S.A. de C.V.:
|
Snake Bite Antivenin Treatment |
Additional relevant MeSH terms:
|
Snake Bites Bites and Stings Poisoning Substance-Related Disorders |
ClinicalTrials.gov processed this record on June 17, 2013