EudraCT: 2009‐016709‐41.

Study name	'Coagulopathy during surgery for the repair of extent 4 thoraco‐abdominal aortic aneurysms ‐ feasibility study of the use of fibrinogen concentrate infusion in place of fresh frozen plasma'
Methods	Type of study: single‐centre randomised controlled trial Follow‐up until: 24 hours postoperatively
Participants	Inclusion: 1. Undergoing elective extent 4 thoracoabdominal aneurysm repair 2. Over 18 years of age 3. Able to give written informed consent Exclusion: 1. Re‐do surgery 2. Surgery for ruptured aneurysm 3. Pregnancy 4. Females of child bearing age (age < 45 years) not using medically approved method of contraception 5. Congenital coagulopathy 6. Known allergy to study drug
Interventions	Intervention arm: Intra‐operative infusion of fibrinogen concentrate 2 g/hour Comparator arm: Intra‐operative transfusion of FFP
Outcomes	Primary outcome: Pattern of coagulation disturbance (individual coagulation factor levels; von Willebrand factor; and thrombin generation) intraoperatively and up to 24 hours postoperatively Other outcomes: 1. Blood loss 2. Red cell, FFP and platelet transfusions intraoperatively 3. Morbidity 4. Length of stay 5. Mortality
Starting date	26 January 2010
Contact information	Principal investigators: Alastair Nimmo (a.nimmo@ed.ac.uk) and Gary Morrison (gary.morrison@luht.scot.nhs.uk)
Notes	—