RiaSTAP vs. Conventional Transfusion in Patients Having Heart Valve Surgery
Status:
Terminated
Trial end date:
2013-05-01
Target enrollment:
Participant gender:
Summary
Heart surgery involving valve replacement often involves the use of the heart-lung machine
for over 90 minutes, and bleeding tendency is frequently seen. Conventionally, platelet
transfusion has been the primary therapy to treat bleeding after this type of procedure. More
recently, perioperative supplementation of purified fibrinogen (RiaSTAP, CSL Behring) was
shown to reduce bleeding and blood product use (plasma or platelets) after heart surgery. The
objective of this trial is to demonstrate the clinical equivalency and economic utility of
using fibrinogen concentrate, RiaSTAP for the mitigation of post-operative bleeding in
patients in lieu of platelet transfusion.
Purified fibrinogen concentrate has been approved by FDA, and it has been used for the
treatment of acute bleeding episodes in patients with low fibrinogen due to hereditary causes
(e.g., afibrinogenemia). Compared to the transfusion of platelets which may be associated
with volume overload, bacterial/viral infection, immunological effects and excess blood
clotting, purified fibrinogen has several advantages. First, it contains no liquid plasma
allowing for low volume infusion. Several viral inactivation/reduction steps are used to
prepare the fibrinogen concentrate, increasing its viral safety. No antibodies or white blood
cells are contained in the fibrinogen concentrate; therefore transfusion reactions are rare.
Although platelet transfusion is widely used after heart surgery, there has been no
randomized study to endorse this practice. In this study, patients undergoing heart valve
replacement will be randomized to receive either platelet (1 unit) transfusion or fibrinogen
concentrate (4g) after heparin anticoagulation is reversed. Subjects will be treated only if
there is evidence of significant microvascular bleeding. Fifteen minutes after the initial
treatment, subjects will be reevaluated for bleeding. If bleeding continues, subjects will be
treated with blood transfusion per institutional standard of care.
The primary endpoints for this study are the hemostatic condition of the surgical field and
24-hour total of blood product transfusion.