Coagulopathy in Patients Having Thoraco-Abdominal Aneurysm Repair Clinical Trial
Official title:
Coagulopathy During Surgery for the Repair of Extent 4 Thoraco-Abdominal Aortic Aneurysms - Feasibility Study of the Use of Fibrinogen Concentrate by Infusion in Place of Fresh Frozen Plasma.
Thoracoabdominal aneurysm (TAAA) repair is a major elective vascular operation associated
with a large blood loss and potentially life-threatening clotting abnormalities. Theses
clotting abnormalities are principally treated using fresh frozen plasma (FFP) (derived from
human blood donations), the administration of which carries a number of risks including
virus transmission (human immunodeficiency virus (HIV), hepatitis B, hepatitis C) and
infection with variant Creutzfeld-Jacob disease (vCJD). FFP is no longer administered to
children or high-usage adults in the UK because of the infection risk, and recently it was
decided by a UK advisory body that the use of UK-derived FFP should cease.
Fibrinogen concentrate is an alternative treatment option to FFP which is thought have less
infection risk (purified, heat treated) and has been in licensed use for many years in other
European countries. The investigators have been using fibrinogen concentrate recently in
their department as an alternative to FFP with encouraging results.
20 patients undergoing elective TAAA repair at The Royal Infirmary of Edinburgh will be
randomly allocated to receive standard treatment (FFP) or fibrinogen concentrate as
treatment for clotting abnormalities during their surgery. The investigators will take a
number of additional blood samples which will provide valuable information about the pattern
of clotting abnormalities during this type of operation. The investigators will also record
blood loss and the number of allogeneic (derived from human donors) blood components
transfused to the patient (red cells, FFP and platelets). Our primary objective is to assess
the pattern of coagulation abnormalities in both groups. We will also examine whether the
use of fibrinogen concentrate during TAAA repair avoids the need to administer FFP.
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