Multicentre randomized clinical trial to investigate the cost-effectiveness of an allogeneic single-donor fibrin sealant after coronary artery bypass grafting (FIBER Study).
BACKGROUND
Reduction of blood transfusion in cardiac surgery is an important target. The aim of this study was to investigate the cost-effectiveness of the use of CryoSeal®, an allogeneic single-donor fibrin sealant, in patients undergoing coronary artery bypass grafting (CABG).


METHODS
This randomized clinical study involved seven cardiac surgery centres in the Netherlands. Patients undergoing elective isolated CABG with the use of at least one internal thoracic artery (ITA) graft were assigned randomly to receive either CryoSeal® (5 ml per ITA bed) or no CryoSeal®. Primary efficacy endpoints were units of transfused red blood cells, fresh frozen plasma and platelet concentrates, and duration of intensive care unit stay. Secondary efficacy endpoints were 48-h blood loss, reoperation for bleeding, mediastinitis, 30-day mortality and duration of hospital stay.


RESULTS
Between March 2009 and January 2012, 1445 patients were randomized. The intention-to-treat (ITT) population comprised 1436 patients; the per-protocol (PP) population 1292. In both the ITT and the PP analysis, no significant difference between the treatment groups was observed for any of the primary and secondary efficacy endpoints. In addition, no significant difference between the groups was seen in the proportion of transfused patients. Estimated CryoSeal® costs were €822 (95 per cent c.i. €808 to €836) per patient, which translated to €72,000 per avoided transfusion (unbounded 95 per cent c.i.).


CONCLUSIONS
The use of the fibrin sealant CryoSeal® did not result in health benefits. Combined with the high cost per avoided transfusion, this study does not support the implementation of routine CryoSeal® use in elective isolated CABG.


BACKGROUND
NTR1386 ( http://www.trialregister.nl).
Departments of Cardiothoracic Surgery, Leiden University Medical Centre, Leiden, The Netherlands.
G
G
Tavilla
Departments of Cardiothoracic Surgery, Leiden University Medical Centre, Leiden, The Netherlands.
E F
EF
Bruggemans
Departments of Cardiothoracic Surgery, Leiden University Medical Centre, Leiden, The Netherlands.
C L I
CL
Gielen
Centre of Clinical Transfusion Research, Sanquin Blood Supply, Leiden, The Netherlands.
A
A
Brand
Departments of Medical Decision-Making, Leiden University Medical Centre, Leiden, The Netherlands.
W B
WB
van den Hout
Departments of Cardiothoracic Surgery, Leiden University Medical Centre, Leiden, The Netherlands.
R J M
RJ
Klautz
Centre of Clinical Transfusion Research, Sanquin Blood Supply, Leiden, The Netherlands.
J A
JA
van Hilten
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D001026:Coronary Artery Bypass; D003362:Cost-Benefit Analysis; D003422:Critical Care / Q000191:economics / Q000706:statistics & numerical data; D017558:Elective Surgical Procedures; D017707:Erythrocyte Transfusion / Q000191:economics / Q000706:statistics & numerical data; D005260:Female; D015718:Fibrin Tissue Adhesive / Q000191:economics / Q000627:therapeutic use*; D006488:Hemostasis, Surgical / Q000191:economics / Q000379:methods*; D006490:Hemostatics / Q000191:economics / Q000627:therapeutic use*; D017721:Hospital Costs / Q000706:statistics & numerical data; D006801:Humans; D057194:Intention to Treat Analysis; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D010949:Plasma; D017713:Platelet Transfusion / Q000191:economics / Q000706:statistics & numerical data
D015718:Fibrin Tissue Adhesive; D006490:Hemostatics