The study was funded by ZonMw Netherlands, Organization for Health, Research and Development, The Hague, The Netherlands (Project 171002206).
Transfusion of fresh-frozen plasma in critically ill patients with a coagulopathy before invasive procedures: a randomized clinical trial (CME)
Version of Record online: 9 JUN 2014
© 2014 AABB
Volume 55, Issue 1, pages 26–35, January 2015
How to Cite
Müller, M. C., Arbous, M. S., Spoelstra-de Man, A. M., Vink, R., Karakus, A., Straat, M., Binnekade, J. M., de Jonge, E., Vroom, M. B. and Juffermans, N. P. (2015), Transfusion of fresh-frozen plasma in critically ill patients with a coagulopathy before invasive procedures: a randomized clinical trial (CME). Transfusion, 55: 26–35. doi: 10.1111/trf.12750
Trial registration: Dutch trial registry NTR2262 and http://www.clinicaltrials.gov NCT01143909.
- Issue online: 13 JAN 2015
- Version of Record online: 9 JUN 2014
- Manuscript Accepted: 4 MAY 2014
- Manuscript Revised: 3 MAY 2014
- Manuscript Received: 19 MAR 2014
- ZonMw Netherlands, Organization for Health, Research and Development, The Hague, The Netherlands. Grant Number: 171002206
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.
Study Design and 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.
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.
In critically ill patients undergoing an invasive procedure, no difference in bleeding complications was found regardless whether FFP was prophylactically administered or not.