Clinical trial NCT01143909: Transfusion of Fresh Frozen Plasma in Non-bleeding Intensive Care Unit (ICU) Patients
Official title: Transfusion of Fresh Frozen Plasma in Non-bleeding ICU Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Coagulation Disorders
Hemorrhage
Keywords: Fresh frozen plasma
Coagulopathy
Intensive care
Adverse effects
Lung injury
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2010-06-15
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Procedure-related relevant bleeding, occurring within 24 hours after the procedure.
timeFrame: 24 hours after the procedure
Secondary outcomes:
measure: minor bleeding within 24 hours
timeFrame: within 24 hours of the procedure
measure: onset of acute lung injury within 48 hours.
timeFrame: 48 hours within the intervention
measure: effect of FFP transfusion on coagulation parameters
timeFrame: within 24 hours of transfusion of FFP
measure: evaluation of costs
timeFrame: up to 28 days after inclusion
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Centre - University of Amsterdam
city: Hilversum
country: Netherlands
facility: Ter Gooi Ziekenhuizen
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
Study officials:
affiliation: Academic Medical Centre - University of Amsterdam
name: Nicole P Juffermans, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Straat M, Muller MC, Meijers JC, Arbous MS, Spoelstra-de Man AM, Beurskens CJ, Vroom MB, Juffermans NP. Effect of transfusion of fresh frozen plasma on parameters of endothelial condition and inflammatory status in non-bleeding critically ill patients: a prospective substudy of a randomized trial. Crit Care. 2015 Apr 15;19(1):163. doi: 10.1186/s13054-015-0828-6.
citation: Muller MC, Straat M, Meijers JC, Klinkspoor JH, de Jonge E, Arbous MS, Schultz MJ, Vroom MB, Juffermans NP. Fresh frozen plasma transfusion fails to influence the hemostatic balance in critically ill patients with a coagulopathy. J Thromb Haemost. 2015 Jun;13(6):989-97. doi: 10.1111/jth.12908. Epub 2015 Apr 18.
citation: Muller MC, de Jonge E, Arbous MS, Spoelstra-de Man AM, Karakus A, Vroom MB, Juffermans NP. Transfusion of fresh frozen plasma in non-bleeding ICU patients--TOPIC trial: study protocol for a randomized controlled trial. Trials. 2011 Dec 23;12:266. doi: 10.1186/1745-6215-12-266.