treatment of envenomation. Toxic effect of snake venom
Conditions
Interventions
Test drug: Snake antivenom immunoglobulin (IgG).
Treatment - Drugs
Test drug: Snake antivenom immunoglobulin (IgG)
Sponsors
Department of health, Governement of Sindh
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteris: Patient envenomed by Saw Scaled Viper (Echis carinatus Sochureki/ lundi) and Russell’s viper (Daboia Russelii/Daman/Koriala); Adult male or female (non-pregnant) above 18 years. Reached hospital within few hours (within 0-7 hours) of snake bite. However the late reaching patients will be treated according to provincial protocol of snakebite management without inclusion in the study; Snake specie is confirmed by identification of dead snake or the clinical observation of incoagulable blood, or when a description of snake is associated with symptoms and signs consistent with systemic envenoming by viper species such as incoagulable blood, spontaneous systemic bleeding, intravascular hemolysis, (pink plasma, anemia, hemoglobinuria), acute renal failure or oliguria; 20WBCT shows incoagulable blood; Patients show no early (anaphylactic) reaction within 10-30 minutes (itching, urticaria, fever, nausea, vomiting, tachycardia, hypotension, bronchospasm) on administration of 0.3ml of test ASV as initial dose; Patient or his/her legally acceptable representative able to understand the informed consent and enter into the study with their free will by signing the same. Exclusion Criteria: Not willing to accept newly produced ASV as the core remedy; Debilitated patients and those with other chronic or complicating medical conditions, any neuropathy, renal impairment, liver diseases, diabetes mellitus, Hypertension and any CV disease; Subject with known hypersensitivity to horse (equine) or sheep (ovine) serum in the past (for example after treatment with equine anti-tetanus serum, equine anti-rabies serum or equine or ovine anti-venom) and those with a strong history of atopic diseases (especially severe asthma); Patients showing reaction to initial dose of test ASV; Patients with severe condition, acute renal failure, anuria, generalized rhabdomyolysis evident with myoglobinuria and haemoglobinuria; Pregnant women and patients under 18 years of age; not bitten by any medically important vipers of Sindh.
Exclusion criteria
Exclusion criteria:
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Early and late snake antivenom reactions. Timepoint: after test dose and ful initial dose patients will be monitored for early reaction while patients will be checked on weekly basis for next 24 days after dosing for late serum reaction. Method of measurement: through clinical sign and symptoms and adverse evnt monitoring. | — |
Primary
| Measure | Time frame |
|---|---|
| Permenant restoration of blood coagulability. Timepoint: 6, 12, 18 and 24 hours after dosing. Method of measurement: measured through 20 minutes whole blood clotting test. | — |
Countries
Pakistan
Contacts
Public ContactProfessor Dr. Allah Bux Ghanghro Principal Scientific Consultant
Institute of Biochemistry University of Sindh Jamshoro
Outcome results
None listed