Home » Trials » SLCTR/2010/011
Does Fresh Frozen Plasma (FFP) in Russell’s viper bite coagulopathy reduce the dose and duration of antivenom therapy?
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SLCTR Registration Number
SLCTR/2010/011
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
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
Fresh Frozen Plasma treatment in Russell's viper bite
Disease or Health Condition(s) Studied
Snake bite
Scientific Acronym
RVFFPS
Public Acronym
RVFFPS
Brief title
Russell's viper FFP study
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
631073NHMRC
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 Viper bite 4. Define the recovery pattern of clotting factors with and without factor replacement in coagulopathy resulting from Russell’s viper bite ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
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
Exclusion criteria
a) Age < 16 years b) Pregnancy c) Definite bite by a snake other than a Russell’s viper
Primary outcome(s)
|
1.
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 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 |
[ 6, 12, 24, daily until discharge (post antivenom treatment) ] |
|
2.
Anaphylaxis: either to antivenom or fresh frozen plasma |
[ 6, 12, 24, daily until discharge (post antivenom treatment) ] |
|
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 |
[ 6, 12, 24, daily until discharge (post antivenom treatment) ] |
|
4.
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) ] |
|
5.
Death prior to discharge from hospital |
[ 6, 12, 24, daily until discharge (post antivenom treatment) ] |
Target number/sample size
Stage 1: 75 patients, Stage 2: 200 patients
Countries of recruitment
Sri Lanka
Anticipated start date
2010-12-12
Anticipated end date
2013-10-31
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
Australian NHMRC
Regulatory approvals
Status
Approved
Date of Approval
2010-08-12
Approval number
2008/EC/26
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Peradeniya |
| Institutional Address: | Galaha Road, Kandy, Sri Lanka |
| Telephone: | +94-812396361 |
| Email: | chairpersonierc@gmail.com |
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
Contact Person for Public Queries
Dr. Indika Gawarammana
Senior Lecturer (Medicine)
SACTRC, Faculty of Medicine, University of Peradeniya, Peradeniya
0814479822
enquiry@sactrc.org
Primary study sponsor/organization
South Asia Clinical Research
SACTRC, Faculty of Medicine, University of Peradeniya, Peradeniya
0814479822
enquiry@sactrc.org
www.sactrc.org
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
