FIBER study

Study Title 

The Fibrin Induced Blood Exposure Reduction (FIBER) Study.

Background

Blood transfusions during or after cardiac operations are linked to many postoperative complications, such as wound infections, pneumonia, renal dysfunction, sepsis, and even in-hospital mortality. In addition, blood transfusions have been associated with increased long-term mortality (1). Consequently, reduction of the frequency of blood transfusions is a major target in the daily practice in the cardiac surgery.

Rational

Fibrin Sealants (FSs) as an adjunct to hemostasis, wound healing, and tissue adhesion are now commercially available for more than 20 years. They have been proved to be efficient in reducing blood loss and the need for blood transfusions in many surgical fields, including cardiac surgery. The use of Sanquin FS, called CryoSeal (CS), therefore, may be an addition to other techniques nowadays used to reduce blood loss, such as the use of antifibrinolytics. FSs have gained increasing popularity as an intervention to reduce blood transfusion requirements, but have been shown to be less effective than antifibrinolytics. However, since one of the most effective antifibrinolytics, aprotinin, has been (temporarily) removed from the market for safety reasons, using FSs may become more significant. Yet, the costs of FSs should legitimate its use. This study has been designed to determine the cost-effectiveness of the use of a CryoSeal from an allogeneic single donor, without the addition of fibrinolysis inhibitors.

Sponsors 

ZonMw and Sanquin Blood Supply.

Study design

Multi-center, randomized controlled intervention study.

Study objective

To investigate the cost-effectiveness of Sanquin’s CryoSeal (CS) in CABG surgery.

Subjects and Sites 

The study has enrolled 1.445 adult patients scheduled for elective, isolated CABG surgery with the use of at least one internal thoracic artery, recruited at seven Dutch study centers.

Intervention

Patients are randomly assigned to receive either CS treatment, up to a maximum of 15 ml CS per patient, or no CS treatment.

Main endpoints

Primary

• Efficacy: Total amount of blood products used within 48 hrs after surgery.
• Costs: Length of ICU stay

Secondary

• Efficacy: Blood loss, Reoperation for bleeding, Wound infection, Mortality
• Costs: Lenght of hospital stay