coagulopathy impaired clotting
Conditions
Interventions
Intervention: omitting prophylactic transfusion of a fixed dose of 12 ml/kg of
FFP prior to an invasive procedure compared to transfusion of a fixed dose of
FFP of 12 ml/kg.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -18 years and older -INR >1.5 and
Exclusion criteria
Exclusion criteria: - clinically overt bleeding at the time of the procedure (excludes minor epistaxis, minor gum bleeding, microscopic hematuria, superficial bruises, or normal menses) - thrombocytopenia of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this study will be a procedure-related relevant bleeding, occurring within 24 hours after the procedure. Relevant bleeding will be defined using a validated tool for assessment of bleeding in the critically ill by: overt bleeding with anyone of the following: -a decrease in haemoglobin by more then 20 g/l in the absence of another cause -transfusion 2 or more units red cells without an increase in haemoglobin -a decrease in systolic blood pressure by more then 20 mmHg -an increase in heart rate of 20 beats/min, -bleeding at a wound site requiring an intervention (for example, re-operation). An assessment of bleeding will be standardized and performed by an independent research physician or intensivist blinded to the transfusion strategy 1 and 24 hours after the procedure and when clinically indicated. The assessment will consist of a physical examination, inspection of chest drain production. Also, haemoglobin will be measured at 1 and 24 hours after the procedure and when clinically indicated. A chest radiograph will be made to capture intra-thoracic bleeding. Hemodynamic parameters (blood pressure and heart rate) will be recorded by an electronic patient data monitoring system. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes: - minor bleeding within 24 hours - onset of acute lung injury within 48 hours. - correction of INR to | — |
Countries
Netherlands
Outcome results
None listed