An interventional study of omitting FFP transfusion before an intervention in Blood Coagulation Disorders and Hemorrhage, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Completed at 4 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-17.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Not applicable, Interventional, and Prevention
With the aim to restrict inappropriate fresh frozen plasma (FFP) transfusions to critically ill patients, a randomized clinical trial will be conducted in a subgroup of intensive care (ICU) patients undergoing an invasive procedure. The objective is to assess the effectiveness and costs of omitting prophylactic FFP transfusion compared to current practice of prophylactic transfusion, in non-bleeding ICU patients with a coagulopathy.
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.
503 studies on the registry are indexed under Hemostatic Disorders; 71 are open to participants now.
This study's enrollment of 81 is above the median of 51 across 253 interventional studies indexed under Hemostatic Disorders.
Browse Hemostatic Disorders studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 512 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
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
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.
In the interventional group FFP transfusion is omitted before performing a procedure (e.g. placement of central venous catheter, tracheostomy, chest tube)
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. 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.
Time frame: 24 hours after the procedure
minor bleeding within 24 hours
Time frame: within 24 hours of the procedure
onset of acute lung injury within 48 hours.
Lung injury will be evaluated by P/F ratio, change in ventilator settings, chest x-ray and Lung Injury Score.
Time frame: 48 hours within the intervention
effect of FFP transfusion on coagulation parameters
a range of coagulation parameters will be evaluated to assess efficacy of FFP transfusion in these patients
Time frame: within 24 hours of transfusion of FFP
evaluation of costs
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.
Time frame: up to 28 days after inclusion
This study is completed, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)