Evaluation of a multi-center randomised clinical trial on prophylactic transfusion of fresh frozen plasma: implications for future trials

• Published in: Transfusion medicine (Oxford, England) Vol. 24; no. 5; pp. 292 - 296
• Main Authors: Müller, M. C. A., de Haan, R. J., Vroom, M. B., Juffermans, N. P.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01-10-2014
• Subjects: Acute Lung Injury - blood; Acute Lung Injury - etiology; Adult; Aged; Blood Coagulation Disorders - blood; Blood Coagulation Disorders - prevention & control; Blood Component Transfusion - adverse effects; Blood Component Transfusion - methods; Critical Illness; critically ill; Female; fresh frozen plasma; Humans; INR; International Normalized Ratio - methods; Male; Middle Aged; Patient Acceptance of Health Care; Plasma; randomised clinical trial; Surveys and Questionnaires; fresh frozen plasma; INR; critically ill; randomised clinical trial
• ISSN: 0958-7578; 1365-3148
• DOI: 10.1111/tme.12151

SUMMARY
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.
Conclusion
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.