Transfusion of Fresh Frozen Plasma in Non-bleeding Intensive Care Unit (ICU) Patients

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)81 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Blood Coagulation Disorders Hemorrhage

Interventions

omitting FFP transfusion before an interventionOTHER

In the interventional group FFP transfusion is omitted before performing a procedure (e.g. placement of central venous catheter, tracheostomy, chest tube)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years and older * INR \>1.5 and \<3.0 * undergoing invasive procedure (insertion of a central venous catheter, a chest drain, percutaneous tracheostomy) 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 \< 30 x 109/L. * use of abciximab, tirofiban, ticlopidine or activated protein C * use of heparin \< 1 hour prior to the procedure, or low molecular weight heparin in therapeutic doses \< 12 hours prior to procedure * history of congenital or acquired coagulation factor deficiency or bleeding diathesis * no informed consent

Locations (4)

Diakonessenhuis

Utrecht, Utrecht, Netherlands

Academic Medical Centre - University of Amsterdam

Amsterdam, Netherlands

Ter Gooi Ziekenhuizen

Hilversum, Netherlands

Leids Universitair Medisch Centrum

Leiden, Netherlands

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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