Snake-Bite. Toxic effect of snake venom
Conditions
Interventions
Intervention 1: Intervention group: Vial containing 10 mL of sterile solution of snake antivenom produced by Padra Serum Alborz which each mL is able to neutralize more than 50 LD50. Initial dose: Mod
Repeat dose: 1 to 6 hours after initial dose, 5 vials until symptom treatment or administration of totally 20 vials
Maintenance dose: 2 vials Infusion every 6 hours up to 3 doses. Intervention 2: Control group: Ampules containing 10 mL of sterile solution of snake antivenom produced by Razi Vaccine and Serum Resear
Repeat dose: 1 to 6 hours after initial dose, 5 ampules until symptom treatment or administration of totally 20 vials
Maintenance dose: 2 ampules Infusion every 6 hours up to 3 doses.
Sponsors
Padra Serum Alborz Company
Eligibility
Sex/Gender
All
Age
2 Years to 60 Years
Inclusion criteria
Inclusion criteria: History of snakebite Informed consent for participating in the study Men or Women victims with age of 2 to 60 years Victims who arrive at mentioned hospitals within 12 hours after snakebite Victims who need anti-venom according to the bite severity scale Victims who have Iranian nationality (having national ID)
Exclusion criteria
Exclusion criteria: Victims with history of allergy to horse serum Victims who have experience of prior treatment with snake or scorpion antivenom due to snakebite or scorpion sting in the past. Victims with two or more number of bites on arrival at hospital. Victims who already have received antivenom prior to reach to hospital. Victims who do wound manipulation (incision, suction, burning and so on) before hospital entrance. Victims with life threatening bleeding (such as bleeding in mouth and upper respiratory tract) Victims who receive heparin and warfarin Victims with history of coagulopathy, cardiac disease, neuromuscular disease, kidney and liver failure. Pregnant or breastfeeding women. Victims who have sea snakebite. Victims who need for mechanical ventilation at the time of registration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of victims with improving in snakebite symptoms. Timepoint: At baseline and 48 hours after antivenom administration. Method of measurement: A) Stopping progression of swelling B) Normalized coagulation abnormalities C) Stopping the progression of neurotoxicity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of adverse events. Timepoint: 0.5, 1, 6, 12, 24, 48, 72 hours, 7 and 14 days after Intervention. Method of measurement: Reporting the incidence proportion.;Dose of antivenom administrated. Timepoint: 0.5, 1, 6, 12, 24, 48, 72 hours after Intervention. Method of measurement: Number of injected vials. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaryam Amini Pouya
Arta Zist Pharmed
Outcome results
None listed