Fresh frozen plasma Coagulopathy Intensive Care Adverse effects Dutch: Plasma Stollingsstoornissen Intensive Care Bijwerkingen
Conditions
Interventions
Omitting prophylactic transfusion of FFP prior to an invasive procedure compared to transfusion of a fixed dose of 12 ml/kg.
Sponsors
Academic Medical Center, Amsterdam, The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients admitted to the ICU of 18 years and older; 2. INR >1,5 and <3,0; 3. Undergoing an invasive procedure, including insertion of a central venous catheter, a chest drain, percutaneous tracheotomy or drainage of abscess or fluid collection.
Exclusion criteria
Exclusion criteria: 1. Clinically overt bleeding at the time of the procedure; 2. Thrombocytopenia <30*109/L; 3. Use of abciximab, tirofiban, ticlopidine or activated protein C; 4. Use of acenocoumarol, fenprocoumon or warfarin; 5. Use of prothrombin complex concentrate prior to procedure; 6. Use of heparin <1 hour before the procedure; 7. Use of therapeutic doses of low molecular weight heparin <12 hours before the procedure; 8. History of congenital or acquired coagulation factor deficiency or bleeding diathesis; 9. No informed consent.
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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Minor bleeding within 24 hours of the intervention; 2. Onset of acute lung injury within 48 hours; 3. Correction of INR to <1,5 (after the transfusion of FFP and before the procedure, only in the transfusion arm); 4. Correction of coagulation variables; 5. Length of ventilation days; 6. Length of ICU stay; 7. ICU mortality; 8. Serious adverse events. | — |
Contacts
Public ContactM.C.A. Muller
Meibergdreef 9
Outcome results
None listed