Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness
Status:
Not yet recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
Fibrinogen concentrate is produced by different manufacturers using different purification
technologies. The products available in Italy are three: RIASTAP (CSL Behring), FIBRYGA
(Octapharma), and FIBRICLOTTE (LFB). RIASTAP and FIBRYGA are sold in 1-gram vials, and
FIBRICLOTTE - in 1.5 grams vials. A recent in vitro study assessed how these products
affected the clot firmness measured by the ROTEM FIBTEM maximum clot firmness (MCF)
parameter. In vitro conditions, FIBRICLOTTE was verified to be the most efficient in
increasing clot firmness.
The present study is aimed to assess, in a series of patients undergoing cardiac surgery with
cardiopulmonary bypass, the hypothesis that the FIBRICLOTTE fibrinogen is superior to the
RIASTAP fibrinogen in increasing the FIBTEM MCF parameter in a clinical model of bleeding
(postoperative bleeding after complex cardiac surgery).