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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000620426

Acronym

ASP - FFP

Enrollment

Registered

2007-12-03

Start date

2008-03-01

Completion date

2012-06-30

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

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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

5 Years to No maximum

Healthy volunteers

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;

Exclusion criteria

Known adverse reactions to blood products

Outcome results