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Trial registered on ANZCTR


Registration number
ACTRN12605000146695
Ethics application status
Approved
Date submitted
10/08/2005
Date registered
15/08/2005
Date last updated
12/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Redback Spider AntiVenom Evaluation (RAVE) Study
Scientific title
Randomised controlled trial of antivenom for the treatment of pain in redback spider bite; intravenous versus intramuscular antivenom.
Universal Trial Number (UTN)
Trial acronym
RAVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Redback spider envenoming 236 0
Condition category
Condition code
Other 267 267 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study compares 2 methods of administration of the same antivenom. The "active" group is intravenous antivenom (500U redback spider antivenom [CSL Ltd] diluted in 200 mL normal saline and given over 20 minutes; patient also receives a dummy intramuscual injection of 0.5mL normal saline).
Intervention code [1] 161 0
Treatment: Drugs
Comparator / control treatment
"Current standard of care" is intramuscular antivenom (500 U redback spider antivenom [CSL Ltd] by intramuscular injection; patient also received a dummy 0.5mL normal saline diluted in 200mL normal saline over 20 minutes.
Control group
Active

Outcomes
Primary outcome [1] 318 0
Clinically important reduction in pain
Timepoint [1] 318 0
2 hours after antivenom treatment
Secondary outcome [1] 705 0
A clinically significant reduction in pain on the VAS on discharge.
Timepoint [1] 705 0
Discharge time
Secondary outcome [2] 706 0
Reduction in systemic symptoms and signs during ED admission.
Timepoint [2] 706 0
By discharge time
Secondary outcome [3] 707 0
Requirement for a third dose or further doses of antivenom.
Timepoint [3] 707 0
By discharge time
Secondary outcome [4] 708 0
Clinically significant change in VAS (or verbal analogue score where the VAS was not obtained).
Timepoint [4] 708 0
At 24 hours.
Secondary outcome [5] 709 0
Use of analgesics in the emergency department after commencing antivenom treatment.
Timepoint [5] 709 0
By discharge time
Secondary outcome [6] 710 0
Use of analgesics after discharge.
Timepoint [6] 710 0
For up to 7 days

Eligibility
Key inclusion criteria
(1) definite redback spider-bite and the spider is identified by the patient or clinician at the time of the bite; OR (2) clinical syndrome that is consistent with typical redback envenoming; AND the treating clinician would normally treat the patient with antivenom, namely: - moderate envenoming = severe local pain without systemic envenoming- severe envenoming = severe local pain and systemic features.
Minimum age
8 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who have received antivenom for this envenoming prior to enrolment2. Children aged <8 years 3. Bite occurring >24 hours ago

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Only the pharmacist knows the allocation. The treatment pack contains 2 ampoules, one labelled "IM" and one labelled "IV" - patient gets both by the allocated routes and onlt the pharmacy knows which is antivenom
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated; blocking.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Comparison of intramuscular and intravenous antivenom, placebo used so that all patients get an IV and IM injection
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2003
Actual
19/01/2003
Date of last participant enrolment
Anticipated
Actual
31/03/2007
Date of last data collection
Anticipated
Actual
31/03/2007
Sample size
Target
400
Accrual to date
Final
130
Recruitment in Australia
Recruitment state(s)
NSW,WA

Funding & Sponsors
Funding source category [1] 324 0
Self funded/Unfunded
Name [1] 324 0
Country [1] 324 0
Primary sponsor type
Individual
Name
Geoff Isbister
Address
Dept of Clinical Toxicology
Calvary Mater Newcastle
Edith St Waratah NSW 2298
Country
Australia
Secondary sponsor category [1] 255 0
None
Name [1] 255 0
Nil
Address [1] 255 0
Country [1] 255 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1237 0
Hunter New England Area Health Service-Newcastle Mater Hospital
Ethics committee address [1] 1237 0
Ethics committee country [1] 1237 0
Australia
Date submitted for ethics approval [1] 1237 0
Approval date [1] 1237 0
Ethics approval number [1] 1237 0
Ethics committee name [2] 1238 0
Hunter New England Area Health Service-John Hunter Hospital
Ethics committee address [2] 1238 0
Ethics committee country [2] 1238 0
Australia
Date submitted for ethics approval [2] 1238 0
Approval date [2] 1238 0
Ethics approval number [2] 1238 0
Ethics committee name [3] 1239 0
Hunter New England Area Health Service-Maitland Hospital
Ethics committee address [3] 1239 0
Ethics committee country [3] 1239 0
Australia
Date submitted for ethics approval [3] 1239 0
Approval date [3] 1239 0
Ethics approval number [3] 1239 0
Ethics committee name [4] 1240 0
Hunter New England Area Health Service-Tamworth Hospital
Ethics committee address [4] 1240 0
Ethics committee country [4] 1240 0
Australia
Date submitted for ethics approval [4] 1240 0
Approval date [4] 1240 0
Ethics approval number [4] 1240 0
Ethics committee name [5] 1241 0
Hunter New England Area Health Service-Belmont Hospital
Ethics committee address [5] 1241 0
Ethics committee country [5] 1241 0
Australia
Date submitted for ethics approval [5] 1241 0
30/10/2002
Approval date [5] 1241 0
02/12/2002
Ethics approval number [5] 1241 0
Ethics committee name [6] 1242 0
Coffs Harbour Hospital
Ethics committee address [6] 1242 0
Ethics committee country [6] 1242 0
Australia
Date submitted for ethics approval [6] 1242 0
Approval date [6] 1242 0
Ethics approval number [6] 1242 0
Ethics committee name [7] 1243 0
Fremantle Hospital
Ethics committee address [7] 1243 0
Ethics committee country [7] 1243 0
Australia
Date submitted for ethics approval [7] 1243 0
Approval date [7] 1243 0
Ethics approval number [7] 1243 0
Ethics committee name [8] 1244 0
Rockingham Hospital
Ethics committee address [8] 1244 0
Ethics committee country [8] 1244 0
Australia
Date submitted for ethics approval [8] 1244 0
Approval date [8] 1244 0
Ethics approval number [8] 1244 0
Ethics committee name [9] 1245 0
Armadale Hospital
Ethics committee address [9] 1245 0
Ethics committee country [9] 1245 0
Australia
Date submitted for ethics approval [9] 1245 0
Approval date [9] 1245 0
Ethics approval number [9] 1245 0
Ethics committee name [10] 1246 0
Bunbury Hospital
Ethics committee address [10] 1246 0
Ethics committee country [10] 1246 0
Australia
Date submitted for ethics approval [10] 1246 0
Approval date [10] 1246 0
Ethics approval number [10] 1246 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35365 0
Prof Geoffrey Isbister
Address 35365 0
Calvary Mater Newcastle
Waratah NSW 2298
Country 35365 0
Australia
Phone 35365 0
o438466471
Fax 35365 0
Email 35365 0
[email protected]
Contact person for public queries
Name 9350 0
Geoff Isbister
Address 9350 0
Department of Clinical Toxicology and Pharmacology
Newcastle Mater Hospital
Edith St
Waratah NSW 2298
Country 9350 0
Australia
Phone 9350 0
+61 2 49211211
Fax 9350 0
Email 9350 0
[email protected]
Contact person for scientific queries
Name 278 0
Geoff Isbister
Address 278 0
Department of Clinical Toxicology and Pharmacology
Newcastle Mater Hospital
Edith St
Waratah NSW 2298
Country 278 0
Australia
Phone 278 0
+61 2 49211211
Fax 278 0
Email 278 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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