| Scientific Title of Trial | Does Fresh Frozen Plasma (FFP) in Russell’s viper bite coagulopathy reduce the dose and duration of antivenom therapy? | |
| Public Title of Trial (in lay language) | Fresh Frozen Plasma treatment in Russell's viper bite | |
| Acronym, if any | RVFFPS | |
| Brief title, if any | Russell's viper FFP study | |
| Any
other number(s) assigned to the trial and issuing authoruty, if any (eg. sponsor, other trial registry) |
631073 NHMRC | |
| Disease or Health Condition(s) studied | Snake bite | |
| What is the research question being addressed? | The aims of this project are to: 1. Determine whether a smaller dose of antivenom (low dose antivenom) in combination with FFP results in more rapid restoration of clotting function in coagulopathic patients bitten by Russell’s vipers compared to standard large dose of antivenom without FFP 2. Determine if the use of low dose antivenom and FFP results in a lower acute reaction rate 3. Confirm the appropriate antivenom doses for coagulopathy in Russell’s vViper bite 4. Define the recovery pattern of clotting factors with and without factor replacement in coagulopathy resulting from Russell’s viper bite ? |
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| Study design | The research will occur in two sequential stages: 1. Stage I: A sequential open-label dose-finding randomised controlled trial of low dose antivenom PLUS fresh frozen plasma versus standard dose antivenom in Russell’s viper coagulopathy 2. Stage II:Open labelled randomised controlled trial of the optimised low dose antivenom PLUS fresh frozen plasma versus standard care in Russell’s viper coagulopathy II. Randomised controlled trial of optimized doses of antivenom/FFP vs standard treatment |
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| Intervention(s) planned | 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 | |
| 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 |
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| Exclusion criteria | a) Age < 16 year b) Pregnancy c) Definite bite by a snake other than a Russell’s viper |
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| Target number / sample size | Stage 1: 75 patients, Stage 2: 200 patients | |
| Primary outcome(s) | 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) | |
| Primary outcome(s) - time of assessment(s) | 6 hours after antivenom treatment | |
| Secondary outcome(s) | 1. 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 2. Anaphylaxis: either to antivenom or fresh frozen plasma 3. 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 4. Other major adverse event, including: a. Transfusion related lung injury b. Renal failure with or without microangiopathic haemolytic anaemia c. Neurotoxicity 5. Death prior to discharge from hospital |
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| Secondary outcome(s) - time of assessment(s) | 6, 12, 24, daily until discharge (post antivenom treatment) | |
| Countries of recruitment | Sri Lanka | |
| Anticipated start date | 02/12/2010 | |
| Anticipated end date | 31/10/2013 | |
| Recruitment status | Recruiting | |
| State of ethics review approval | Approved by University of Peradeniya, University of Newcastle, Australia | |
| Funding source(s) | Australian NHMRC | |
| Applicant's Email | geoff.isbister@gmail.com | |
| Approval Status | Approved | |
| Contact Person for Scientific Queries / Principal investigator | Goeff Isbister
Associate Professor & Clinician Researcher Department of Clinical Toxicology, Calvary Mater Newcastle, Edith, Street, Waratah NSW 2298, Australia 0061438466471 geoff.isbister@gmail.com |
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| Primary Study Sponsor/ Organization | South Asia Clinical Research
SACTRC, Faculty of Medicine, University of Peradeniya, Peradeniya 0814479822 0814479822 enquiry@sactrc.org www.sactrc.org |
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| Contact Person for Public Queries | Dr. Indika Gawarammana Senior Lecturer (Medicine) SACTRC, Faculty of Medicine, University of Peradeniya, Peradeniya 0814479822 0814479822 enquiry@sactrc.org |
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| Secondary Study Sponsor(s), (if any) | None |
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