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Fresh Frozen Plasma treatment in Russell's viper bite

Does Fresh Frozen Plasma (FFP) in Russell’s viper bite coagulopathy reduce the dose and duration of antivenom therapy?

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2010/011
Enrollment
Unknown
Registered
2010-12-02
Start date
2010-12-12
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Snake bite

Interventions

FFP (5 ml/Kg) plus low dose anti venom (10 vials), FFP (10 ml/Kg) plus standard dose anti venom (20 vials), Only standard dose anti venom

Sponsors

South Asia Clinical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a) Suspected or confirmed Russell’s viper bite b) Venom induced consumption coagulopathy defined as: WBCT > 20 minutes c) No known hypersenstivity to blood products d) FFP is available and can be given to the patient within 4 hours of commencing antivenom

Exclusion criteria

Exclusion criteria: a) Age < 16 years b) Pregnancy c) Definite bite by a snake other than a Russell’s viper

Design outcomes

Primary

MeasureTime frame
The primary outcome will be the proportion of patients with a return of near-normal coagulation function defined by an INR < 2.0 measured (6 hours after antivenom treatment was commenced) [6 hours after antivenom treatment]—

Secondary

MeasureTime frame
Recurrence of envenoming: a. Increase in INR above 2.0 in responding patients (INR<2 at 6 hours) b. Re-appearance of venom in serum detected by EIA [6, 12, 24, daily until discharge (post antivenom treatment)] Anaphylaxis: either to antivenom or fresh frozen plasma [6, 12, 24, daily until discharge (post antivenom treatment)] Major bleeding as defined by the International Society on Thrombosis and Haemostasis19: a. Fatal bleeding b. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial c. 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 [6, 12, 24, daily until discharge (post antivenom treatment) ] Other major adverse event, including: a. Transfusion related lung injury b. Renal failure with or without microangiopathic haemolytic anaemia c. Neurotoxicity [6, 12, 24, daily until discharge (post antivenom treatment) ] Death prior to discharge from hospital [6, 12, 24, daily until discharge (post antivenom treatment) ]—

Countries

Sri Lanka

Contacts

Public ContactGoeff Isbister

Associate Professor & Clinician Researcher

geoff.isbister@gmail.com0061438466471

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026