Fibrinogen as an alternative to FFP in aortic surgery.
Research type
Research Study
Full 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.
IRAS ID
26862
Contact name
Alastair Nimmo
Sponsor organisation
NHS Lothian
Eudract number
2009-016709-41
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
Thoraco-Abdominal Aortic Aneurysm (TAAA) repair is a major elective vascular operation associated with a large blood loss and potentially life-threatening clotting abnormalities. These clotting abnormalities are commonly treated using Fresh Frozen Plasma (FFP) (derived from human blood donations), the administration of which carries a number of risks including virus transmission (hepatitis B, C, and HIV) and infection with variant Creutzfeld-Jacob disease (vCJD). There is also a significant delay in obtaining FFP from the Blood Bank before it can be administered. FFP is no longer given 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 to have less infection risk (purified, heat treated) and has been in licensed use for many years in other European countries. We have been using fibrinogen concentrate recently in our 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. We will take additional blood samples which will provide detailed information about the pattern of clotting abnormalities around the time of surgery in both treatment groups. We 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). We will aim to accurately characterise and compare the nature of clotting abnormalities in both treatment groups, and assess whether the use of Fibrinogen Concentrate during TAAA repair removes the need to administer FFP.
REC name
Scotland A REC
REC reference
09/MRE00/89
Date of REC Opinion
15 Dec 2009
REC opinion
Favourable Opinion