A randomised controlled trial of antivenom for red-bellied black snake envenoming

A multicentre double-blind randomised placebo-controlled trial of early antivenom versus placebo in the treatment of red bellied black snake envenoming

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000588998

Acronym

RBBS RCT

Enrollment

Registered

2011-06-07

Start date

2014-04-01

Completion date

Unknown

Last updated

2020-02-03

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

Conditions

None listed

Brief summary

Muscle damage can result from snake bite which is irreversible and there is no specific treatment for except antivenom. Redbellied black snake bite provides a unique opportunity to study antivenom use in muscle damage in snake bite because this snake occurs across large population areas of NSW and Queensland. The study will determine if antivenom is effective and safe in red bellied black snake bite and whether it is therefore useful for other important snakes that cause muscle damage worldwide.

Interventions

The study tests two treatments in two arms: 1. 1 vial of tiger snake antivenom (3000 Units) 2. A matched volume of 50% glucose (Placebo) Antivenom = 1 vial of Tiger snake antivenom (3000 Units; CSL Ltd) given intravenously diluted in 200mL of normal saline over 20 minutes.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

2 Years to 99 Years

Healthy volunteers

Inclusion criteria

1. Definite bite by a red-bellied black snake: a.Expert identification of the snake or snake brought in and identified by a photograph sent to the investigators; OR b.Characteristic description of a RBBS (black snake with red sides and cream/yellow ventral surface) AND detection of black snake (or black snake/tiger snake) on a snake venom detection kit. 2. Early evidence of envenoming (any of): a. Non-specific systemic effects including two of nausea/vomiting, headache, abdominal pain, diarrhoea b. Anticoagulant coagulopathy defined as an activated partial thromboplastin time above the normal range for the local laboratory c. Significant local tissue injury with swelling, bruising and erythema >5 cm diameter

Exclusion criteria

Nil

Outcome results