ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12607000620426

Ethics application status

Approved

Date submitted

9/10/2007

Date registered

3/12/2007

Date last updated

12/08/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

A Randomised Controlled Trial Of Factor Replacement Therapy In Snake Bite Coagulopathy

Scientific title

A Randomised Controlled Trial Of Fresh Frozen Plasma (FFP) for Venom Induced Consumption Coagulopathy in Australian snakebite

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

ASP - FFP

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Venom Induced Consumption Coagulopathy (VICC) from Australian snake envenoming

Condition category

Condition code

Injuries and Accidents

Other injuries and accidents

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Fresh frozen plasma (FFP), 6 units administered within 4 hours of antivenom treatment

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

No treatment defined as no administration of FFP or other clotting factors within 4 hours of antivenom.

Control group

Placebo

Outcomes

Primary outcome [1]

The proportion of patients with a return of coagulation function defined by an International Normalised Ratio (INR) < 2.0 (or PT < 24 seconds where INR is not performed)

Timepoint [1]

Six hours after antivenom treatment commenced

Secondary outcome [1]

Pattern of improvement in clotting function and increase in clotting factors: fibrinogen, prothrombin, factor V and factor VIII. Blood samples will be taken prior to antivenom, 3,6 12 and 24 hours after antivenom.

Timepoint [1]

investigation of improvement of multiple clotting factors over time.

Secondary outcome [2]

The number of hours after commencing antivenom until discharge from hospital (hours).

Timepoint [2]

Time from commencing antivenom until discharge from hospital (hours)

Secondary outcome [3]

Major bleeding, as defined by the International Society on Thrombosis and Haemostasis: Fatal bleeding; Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome; Bleeding causing a fall in haemoglobin level of 20 g/L or more, or leading to transfusion of two or more units of whole blood or red cells.

Timepoint [3]

While in hospital

Secondary outcome [4]

Death

Timepoint [4]

While in hospital

Secondary outcome [5]

Adverse reactions

Timepoint [5]

While in hospital

Eligibility

Key inclusion criteria

1. Venom induced consumption coagulopathy defined as: an INR (or PT) or aPTT more than twice the normal upper limit AND a positive D-dimer;
2. Antivenom administered for the appropriate snake: brown, tiger or taipan;
3. 6 units of FFP is available and can be administered to the patient within 4 hours of commencing antivenom, either at the presenting hospital or on arrival at a regional hospital nearby if transfer can be initiated in time;

Minimum age

5 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Known adverse reactions to blood products

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)

Patients will be enrolled from cases of snake envenoming identified to the principal investigators from around Australia. Cases that meet the inclusion criteria will be randomised centrally in a 2:1 schedule to either receive fresh frozen plasma or no treatment following the administration of antivenom. Blinded allocation will be maintained by the investigators and research assistants by using the PDAs to provide the random allocation. A Microsoft Access database form (reduced version for PDAs) will be used to implement this. The investigator must first enter the patient’s baseline characteristics and non-identifiable information which will allow recruitment. If the patient meets criteria to be randomised for FFP treatment then further information will need to be entered (coagulation studies results, consent obtained and FFP available). Once this has been supplied the program will then randomise and allocate the patient for the study. This will mean that the investigator and treating doctor will not be aware of the allocation until the patient is eligible for recruitment and they have consented.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer generated random sequence using Microsoft Excel.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

2:1 randomisation because of the chance that patients randomised to fresh frozen plasma may not actually be given fresh frozen plasma within the time frame for logistic reasons.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/01/2008

Actual

1/03/2008

Date of last participant enrolment

Anticipated

Actual

30/06/2012

Date of last data collection

Anticipated

Actual

30/06/2012

Sample size

Target

102

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD,SA,WA

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHRMC Project Grant

Address [1]

Canberra

Country [1]

Australia

Primary sponsor type

Individual

Name

Geoffrey Isbister

Address

Calvary Mater Newcastle
Edith St
Waratah NSW 2298

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Simon Brown

Address [1]

Emergency Research Unit
Fremantle Hospital
Fremantle

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

01/11/2007

Approval date [1]

Ethics approval number [1]

Ethics committee name [2]

Hunter and New England HREC

Ethics committee address [2]

Newcastle

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

30/10/2007

Approval date [2]

29/11/2007

Ethics approval number [2]

07/11/21/3.06

Summary

Brief summary

The study aims to determine if the early administration of clotting factors (ie. FFP) to patients with a procoagulant coagulopathy following snake envenoing will speed the patient recovery of clotting function. A secondary aim to confirm that smaller doses of antivenom are sufficient for the treatment of coagulopathy.

Trial website

Trial related presentations / publications

Isbister GK, Buckley NA, Page CB, et al. A randomized controlled trial of fresh frozen plasma for treating venom-induced consumption coagulopathy in cases of Australian snakebite (ASP-18). J Thromb Haemost 2013; 11(7): 1310-8

Public notes

Contacts

Principal investigator

Name

Prof Geoffrey Isbister

Address

Calvary Mater Newcastle
Waratah NSW 2298

Country

Australia

Phone

0438466471

Fax

[email protected]

Contact person for public queries

Name

Geoff Isbister

Address

Calvary Mater Newcastle
Edith St
Waratah NSW 2298

Country

Australia

Phone

02 49211211

Fax

02 94754893

[email protected]

Contact person for scientific queries

Name

Geoff Isbister

Address

Calvary Mater Newcastle
Edith St
Waratah NSW 2298

Country

Australia

Phone

02 49211211

Fax

02 94754893

[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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	A randomized controlled trial of fresh frozen plasma for treating venom-induced consumption coagulopathy in cases of Australian snakebite (ASP-18)	2013	https://doi.org/10.1111/jth.12218

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically