title: Transfusion of fresh-frozen plasma in critically ill patients with a coagulopathy before invasive procedures: a randomized clinical trial (CME).
abstract: BACKGROUND
  Prophylactic use of fresh-frozen plasma (FFP) is common practice in patients with a coagulopathy undergoing an invasive procedure. Evidence that FFP prevents bleeding is lacking, while risks of transfusion-related morbidity after FFP have been well demonstrated. We aimed to assess whether omitting prophylactic FFP transfusion in nonbleeding critically ill patients with a coagulopathy who undergo an intervention is noninferior to a prophylactic transfusion of FFP.
  
  
  METHODS
  A multicenter randomized open-label trial with blinded endpoint evaluation was performed in critically ill patients with a prolonged international normalized ratio (INR; 1.5-3.0). Patients undergoing placement of a central venous catheter, percutaneous tracheostomy, chest tube, or abscess drainage were eligible. Patients with clinically overt bleeding, thrombocytopenia, or therapeutic use of anticoagulants were excluded. Patients were randomly assigned to omitting or administering a prophylactic transfusion of FFP (12 mL/kg). Outcomes were occurrence of postprocedural bleeding complications, INR correction, and occurrence of lung injury.
  
  
  RESULTS
  Due to slow inclusion, the trial was stopped before the predefined target enrollment was reached. Eighty-one patients were randomly assigned, 40 to FFP and 41 to no FFP transfusion. Incidence of bleeding did not differ between groups, with a total of one major and 13 minor bleedings (p = 0.08 for noninferiority). FFP transfusion resulted in a reduction of INR to less than 1.5 in 54% of transfused patients. No differences in lung injury scores were observed.
  
  
  CONCLUSIONS
  In critically ill patients undergoing an invasive procedure, no difference in bleeding complications was found regardless whether FFP was prophylactically administered or not.
authors.affiliation: Department of Intensive Care Medicine, Academic Medical Center, Amsterdam, the Netherlands.
authors.forename: Marcella C
authors.initials: MC
authors.lastname: Müller
authors.forename: M Sesmu
authors.initials: MS
authors.lastname: Arbous
authors.forename: Angelique M
authors.initials: AM
authors.lastname: Spoelstra-de Man
authors.forename: Roel
authors.initials: R
authors.lastname: Vink
authors.forename: Atilla
authors.initials: A
authors.lastname: Karakus
authors.forename: Marleen
authors.initials: M
authors.lastname: Straat
authors.forename: Jan M
authors.initials: JM
authors.lastname: Binnekade
authors.forename: Evert
authors.initials: E
authors.lastname: de Jonge
authors.forename: Margreeth B
authors.initials: MB
authors.lastname: Vroom
authors.forename: Nicole P
authors.initials: NP
authors.lastname: Juffermans
mesh_terms: D000038:Abscess / Q000601:surgery; D055371:Acute Lung Injury / Q000453:epidemiology; D000368:Aged; D002405:Catheterization, Central Venous / Q000009:adverse effects; D015505:Chest Tubes / Q000009:adverse effects; D016638:Critical Illness / Q000628:therapy*; D004322:Drainage / Q000009:adverse effects; D005260:Female; D006470:Hemorrhage / Q000453:epidemiology / Q000517:prevention & control*; D006474:Hemorrhagic Disorders / Q000628:therapy*; D006801:Humans; D007362:Intensive Care Units / Q000706:statistics & numerical data; D019934:International Normalized Ratio; D007902:Length of Stay / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D010949:Plasma; D011300:Preoperative Care / Q000379:methods; D011677:Punctures / Q000009:adverse effects*; D012121:Respiration, Artificial / Q000009:adverse effects; D012720:Severity of Illness Index; D016037:Single-Blind Method; D014139:Tracheostomy / Q000009:adverse effects; D016896:Treatment Outcome; D019564:Unnecessary Procedures