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Randomised controlled trial investigating the effects of early snake antivenom administration

Randomised controlled trial investigating the effects of early snake antivenom administration

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000264583
Acronym
ESAA
Enrollment
1
Registered
2015-03-20
Start date
2015-10-26
Completion date
2015-10-26
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Currently, standard practice for any snake bite requires laboratory testing to determine if a patient has been envenomed, and coagulation studies are the most important tests. The administration of antivenom is then based on the presence of clinical effects of envenoming and abnormal laboratory investigations. However, many of these envenoming effects are irreversible, so once they develop they are unlikely to be reversed by antivenom. In this case, antivenom needs to be given prior to the development of abnormal laboratory test or clinical effects. The aim of this project will be to administer antivenom early – as soon as the patient presents to hospital, without first waiting for laboratory tests or the development of clinical signs of envenoming, and/or retrieval to a major hospital. The objective is to prevent envenoming effects that may lead to significant morbidity or death.

Interventions

a)tiger snake and brown snake antivenom b)1 vial of tiger snake antivenom (3000 units), 1 vial of brown snake antivenom (1000 units) c) Administered once d) Intravenous administration e)Administration of snake antivenom will be as soon as patient presents to hospital and consents to participation

Sponsors

University of Newcastle
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
2 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Presents to hospital within 2 hours of snakebite 2. Definite sighting of a snake by the patient (or parent/carer of child, age >2years) and a confirmed bite. 3. Early non-specific systemic symptoms suggesting envenoming: EITHER: collapse OR two of vomiting, headache, diarrhoea or abdominal pain.

Exclusion criteria

1. Aged under 2 years of age 2. Definite bite by a non-venomous snake 3. Definite bite by a red-bellied black snake at hospitals where a separate study is being undertaken (Hunter Area Health Hospitals, Manning Base Hospital, Coffs Harbour Hospital, Liverpool Hospital, Campbelltown Hospital) 4. Suspected taipan bites (in northern regions of Australia where taipans occur) 5. Cases consistent with mulga snake envenoming 6. Cases consistent with death adder envenoming 7. Cardiac Arrest.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026