title: Transfusion of fresh frozen plasma in non-bleeding ICU patients--TOPIC trial: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  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. With the aim to investigate whether prophylactic FFP transfusions to critically ill patients can be safely omitted, a multi-center randomized clinical trial is conducted in ICU patients with a coagulopathy undergoing an invasive procedure.
  
  
  METHODS
  A non-inferiority, prospective, multicenter randomized open-label, blinded end point evaluation (PROBE) trial. In the intervention group, a prophylactic transfusion of FFP prior to an invasive procedure is omitted compared to transfusion of a fixed dose of 12 ml/kg in the control group. Primary outcome measure is relevant bleeding. Secondary outcome measures are minor bleeding, correction of International Normalized Ratio, onset of acute lung injury, length of ventilation days and length of Intensive Care Unit stay.
  
  
  CONCLUSIONS
  The Transfusion of Fresh Frozen Plasma in non-bleeding ICU patients (TOPIC) trial is the first multi-center randomized controlled trial powered to investigate whether it is safe to withhold FFP transfusion to coagulopathic critically ill patients undergoing an invasive procedure.
  
  
  BACKGROUND
  Trial registration: Dutch Trial Register NTR2262 and ClinicalTrials.gov: NCT01143909.
authors.affiliation: Department of Intensive Care Medicine, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands. m.c.muller@amc.uva.nl
authors.forename: Marcella C A
authors.initials: MC
authors.lastname: Müller
authors.forename: Evert
authors.initials: E
authors.lastname: de Jonge
authors.forename: M Sesmu
authors.initials: MS
authors.lastname: Arbous
authors.forename: Angelique M E
authors.initials: AM
authors.lastname: Spoelstra-de Man
authors.forename: Atilla
authors.initials: A
authors.lastname: Karakus
authors.forename: Margreeth B
authors.initials: MB
authors.lastname: Vroom
authors.forename: Nicole P
authors.initials: NP
authors.lastname: Juffermans
mesh_terms: D016913:Blood Component Transfusion; D002985:Clinical Protocols; D006801:Humans; D007362:Intensive Care Units; D010949:Plasma