Russell’s Viper Coagulopathy Fresh Frozen Plasma Study

Randomised controlled trial of fresh frozen plasma to speed the recovering of venom induced consumption coagulopathy in patients with Russell's Viper envenoming in Sri Lanka.

Status

Withdrawn

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000611325

Enrollment

700

Registered

2008-12-05

Start date

2008-10-01

Completion date

Unknown

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

This study is a controlled trial of factor replacement (fresh frozen plasma) in snake bite coagulopathy from Russell's viper bite, after a neutralising dose of antivenom to determine whether it will result in a rapid return of clotting function.

Interventions

Intravenous fresh frozen plasma, 10mL/kg up to 4 units, within 4 hours of the commencement of first antivenom therapy. Antivenom treatment will be according to the current recommendation in Sril Lanka of 20 vials of Indian polyvalent antisnake venom (VINS or Haffkine) administered over 1 hour intravenously.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

14 Years to No maximum

Healthy volunteers

Inclusion criteria

a) Venom induced consumption coagulopathy defined as: whole blood clotting time (WBCT) > 20 minutes b) No known adverse reactions to blood products c) Antivenom is or will be administered to treat the patient d) Up to a maximum of 4 units of FFP is available and can be commenced to the patient within 4 hours of commencing antivenom.

Exclusion criteria

a) Age < 14 year b) Pregnancy

Outcome results