A Phase 4 interventional study of A and Antivipmyn ® in Snake Bite, sponsored by Instituto Bioclon S.A. de C.V.. Terminated at 5 sites in Mexico. Open to participants aged 6 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-07-20.
Sponsored by Instituto Bioclon S.A. de C.V. (part of Laboratorios Silanes S.A. de C.V.) · Phase 4, Interventional, and Treatment
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.
38 studies on the registry are indexed under Snake Bites; 11 are open to participants now.
This study's enrollment of 10 is below the median of 70 across 18 interventional studies indexed under Snake Bites.
Browse Snake Bites studies →Instituto Bioclon S.A. de C.V. is the lead sponsor of 11 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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 up front in a Single Dose of Antivipmyn
Also known as: Crotalinae (pit viper) equine immune F(ab)2
20 vials fractionated into 4 doses of 5 vials each of Antivipmyn ®
Also known as: Crotalinae (pit viper) equine immune F(ab)2
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
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
Plan to share: Undecided — Not yet decided
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This study is terminated, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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