Phase 3, multi-center clinical trial for evaluation of two types of snake anti-venom

Phase 3

• Conditions: Snake-Bite.; Toxic effect of snake venom; T63.0

• Registration Number: IRCT20180515039672N2
• Lead Sponsor: Padra Serum Alborz Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 98

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

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.