Transfusion of Fresh Frozen Plasma in Non-bleeding Intensive Care Unit (ICU) Patients (TOPIC)
|ClinicalTrials.gov Identifier: NCT01143909|
Recruitment Status : Completed
First Posted : June 15, 2010
Last Update Posted : June 17, 2013
|Condition or disease||Intervention/treatment||Phase|
|Blood Coagulation Disorders Hemorrhage||Other: omitting FFP transfusion before an intervention||Not Applicable|
Rationale: Fresh frozen plasma (FFP) is an effective therapy to correct for a deficiency of multiple coagulation factors during bleeding. In past years, use of FFP has increased, in particular in patients on the Intensive Care Unit (ICU), and has expanded to include prophylactic use in patients with a coagulopathy prior to undergoing an invasive procedure. Retrospective studies suggest that prophylactic use of FFP does not prevent bleeding, but carries the risk of transfusion-related morbidity. However, up to 50% of FFP is administered to non-bleeding ICU patients.
Objective: With the aim to restrict inappropriate FFP transfusions to critically ill patients, a randomized clinical trial will be conducted in a subgroup of ICU patients with a coagulopathy undergoing an invasive procedure. The objective is to assess the effectiveness and costs of prophylactic FFP transfusion (current practice) compared to no prophylactic transfusion, in non-bleeding ICU patients with a coagulopathy, prior to undergoing an invasive procedure (e.g. placement of central venous catheter, tracheostomy, chest tube).
Study design: Prospective, multicentre, randomized, open-label, blinded end point evaluation (PROBE) design.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Transfusion of Fresh Frozen Plasma in Non-bleeding ICU Patients|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Experimental: No FFP transfusion prior to intervention
Patients with a coagulopathy (INR 1,5-3,0), who are randomized to omitting transfusion of fresh frozen plasma before they undergo an intervention.
Other: omitting FFP transfusion before an intervention
In the interventional group FFP transfusion is omitted before performing a procedure (e.g. placement of central venous catheter, tracheostomy, chest tube)
No Intervention: FFP transfusion prior to intervention
Patients with a coagulopathy (INR 1,5-3,0), who are randomized to transfusion of fresh frozen plasma before they undergo an intervention. This is considered standard care.
- Procedure-related relevant bleeding, occurring within 24 hours after the procedure. [ Time Frame: 24 hours after the procedure ]
Relevant bleeding will be defined using a validated tool for assessment of bleeding in the critically ill.
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.
- minor bleeding within 24 hours [ Time Frame: within 24 hours of the procedure ]
- onset of acute lung injury within 48 hours. [ Time Frame: 48 hours within the intervention ]Lung injury will be evaluated by P/F ratio, change in ventilator settings, chest x-ray and Lung Injury Score.
- effect of FFP transfusion on coagulation parameters [ Time Frame: within 24 hours of transfusion of FFP ]a range of coagulation parameters will be evaluated to assess efficacy of FFP transfusion in these patients
- evaluation of costs [ Time Frame: up to 28 days after inclusion ]Evaluation of costs in the two different groups will be made. Length of stay, number of ventilation days, differences in medication use, all will be taken into account.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01143909
|Academic Medical Centre - University of Amsterdam|
|Amsterdam, Netherlands, 1105 AZ|
|Ter Gooi Ziekenhuizen|
|Hilversum, Netherlands, 1231 XZ|
|Leids Universitair Medisch Centrum|
|Leiden, Netherlands, 2333 XZ|
|Utrecht, Netherlands, 3582 KE|
|Principal Investigator:||Nicole P Juffermans, MD, PhD||Academic Medical Centre - University of Amsterdam|