title: Evaluation of a multi-center randomised clinical trial on prophylactic transfusion of fresh frozen plasma: implications for future trials.
abstract: BACKGROUND
  Prophylactic use of fresh frozen plasma (FFP) in critically ill patients with a coagulopathy is common. However, a lack of evidence of efficacy has resulted in a call for trials on the benefit of FFP in these patients. To date, conducting a trial on this subject has not been successful. Recently, a multi-center randomised trial was stopped prematurely due to slow inclusion.
  
  
  OBJECTIVE
  To assess clinicians' opinions regarding a trial on prophylactic administration of FFP in coagulopathic critically ill patients who need to undergo an intervention.
  
  
  METHODS
  A survey among 55 intensivists who all participated in a randomised trial on the risks and benefits of FFP in critically ill patients.
  
  
  RESULTS
  Response rate was 84%. Majority of respondents indicated that international normalised ratio (INR) should be assessed before insertion of a central venous catheter (CVC) (61%), chest tube (89%) or tracheostomy (91%). Reasons to withhold transfusion of FFP to non-bleeding critically ill patients are risk of transfusion-related acute lung injury (TRALI) (46%), fluid overload (39%) and allergic reaction (24%). Although, the majority of respondents expressed the opinion that the trial was clinically relevant, 56% indicated that ≥1 patient subgroups should have been excluded from participation.
  
  
  CONCLUSIONS
  Intensivists express the need for more evidence on the prophylactic use of FFP in coagulopathic critically ill patients. However, lack of knowledge about FFP and personal beliefs about the preferable transfusion strategy among clinicians, resulted in premature termination of a clinical trial on this topic.
authors.affiliation: Department of Intensive Care Medicine, Academic Medical Center, Amsterdam, the Netherlands.
authors.forename: M C A
authors.initials: MC
authors.lastname: Müller
authors.forename: R J
authors.initials: RJ
authors.lastname: de Haan
authors.forename: M B
authors.initials: MB
authors.lastname: Vroom
authors.forename: N P
authors.initials: NP
authors.lastname: Juffermans
mesh_terms: D055371:Acute Lung Injury / Q000097:blood / Q000209:etiology; D000328:Adult; D000368:Aged; D001778:Blood Coagulation Disorders / Q000097:blood / Q000517:prevention & control*; D016913:Blood Component Transfusion / Q000009:adverse effects / Q000379:methods*; D016638:Critical Illness; D005260:Female; D006801:Humans; D019934:International Normalized Ratio / Q000379:methods; D008297:Male; D008875:Middle Aged; D010342:Patient Acceptance of Health Care; D010949:Plasma; D011795:Surveys and Questionnaires
keywords: INR; critically ill; fresh frozen plasma; randomised clinical trial