Coagulation
Conditions
Keywords
Plasma, Trauma, Critical Care
Brief summary
Measuring the effectiveness of plasma transfusions in critical care
Detailed description
Measuring the effectiveness of plasma transfusions in critical care
Interventions
DRUGFrozen Plasma
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* ICU Admission * INR \> 1.2 * Require FFP for active bleeding and/or prior to an invasive procedure * Are able to provide consent or proxy consent
Exclusion criteria
* Congenital or acquired coagulation factor deficiency * Platelet count \< 50 x 109 /L and have NOT received subsequent platelet transfusion * Consumptive coagulopathy (bleeding ≥ 3 sites and ↓ plts, ↓ fib, ↑ d dimer) * Uncontrolled bleeding (6 or more units of blood in the last 6 hours) * Receiving therapeutic doses of heparin/heparinoid (must be off for at least 6 hours) * Have received clotting factor concentrates in the previous 24 hours * Are expected to require surgery in the next 48 hours * Survival expected to be less than 48 hours * Currently enrolled in another study with a similar outcome * Previous enrollment in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the proportion of patients with a correction of the INR (Determined by the treating physician) | — |
| Secondary outcomes include changes in coagulation tests (INR, aPTT and individual coagulation factor levels | — |
| bleeding and complications from FFP (fluid overload, transfusion reactions). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include changes in coagulation tests (INR, aPTT and individual coagulation factor levels | — |
| bleeding and complications from FFP (fluid overload, transfusion reactions). | — |
Countries
Canada
Outcome results
None listed