Fibrinogen as an Alternative to FFP in Aortic Surgery.
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.
Coagulopathy in Patients Having Thoraco-Abdominal Aneurysm Repair
Biological: Fibrinogen concentrate
Biological: Fresh Frozen Plasma
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|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.|
- Pattern of coagulation disturbance in the conventional treatment (FFP) and fibrinogen concentrate groups. [ Time Frame: Inra-operatively, and up to 24 hours post-operatively. ] [ Designated as safety issue: No ]
- Proportion of patients in the fibrinogen group in whom FFP transfusion is required during surgery. [ Time Frame: Operative period. ] [ Designated as safety issue: No ]
- Units of FFP transfused - during surgery and up to 24 hours after surgery. [ Time Frame: Peri-operative period. ] [ Designated as safety issue: No ]
- Units of platelets and allogeneic red cells transfused - during surgery and up to 24 hours after surgery. [ Time Frame: Peri-operative period. ] [ Designated as safety issue: No ]
- Blood loss. [ Time Frame: Operative period. ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Active Comparator: Fresh Frozen Plasma||Biological: Fresh Frozen Plasma|
|Experimental: Fibrinogen concentrate||
Biological: Fibrinogen concentrate
Fibrinogen concentrate will be administered initially at 2 grammes per hour by continuous infusion. This rate will be adjusted in response to the clinical picture and results of point of care coagulation tests. The infusion will be used intra-operatively.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994045
|Contact: Alastair Nimmo, MBChB||0131 242 3224 ext firstname.lastname@example.org|
|Contact: Gary A Morrison, MBChB||0131 242 3224 ext email@example.com|
|The Royal Infirmary of Edinburgh||Recruiting|
|Edinburgh, United Kingdom, EH16 4SA|
|Principal Investigator:||Alastair Nimmo, MBChB||NHS Lothian|