A Randomised Controlled Trial Of Factor Replacement Therapy In Snake Bite Coagulopathy
Not Applicable
Completed
- Conditions
- Venom Induced Consumption Coagulopathy (VICC) from Australian snake envenomingInjuries and Accidents - Other injuries and accidents
- Registration Number
- ACTRN12607000620426
- Lead Sponsor
- Geoffrey Isbister
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 102
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of patients with a return of coagulation function defined by an International Normalised Ratio (INR) < 2.0 (or PT < 24 seconds where INR is not performed)[Six hours after antivenom treatment commenced]
- Secondary Outcome Measures
Name Time Method Pattern of improvement in clotting function and increase in clotting factors: fibrinogen, prothrombin, factor V and factor VIII. Blood samples will be taken prior to antivenom, 3,6 12 and 24 hours after antivenom.[investigation of improvement of multiple clotting factors over time.];The number of hours after commencing antivenom until discharge from hospital (hours).[Time from commencing antivenom until discharge from hospital (hours)];Major bleeding, as defined by the International Society on Thrombosis and Haemostasis: Fatal bleeding; Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome; 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.[While in hospital];Death[While in hospital];Adverse reactions[While in hospital]