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Fibrinogen as an Alternative to FFP in Aortic Surgery.

This study has been completed.
NHS Lothian
CSL Behring
Information provided by (Responsible Party):
Alastair Nimmo, University of Edinburgh Identifier:
First received: October 13, 2009
Last updated: January 28, 2017
Last verified: January 2017

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.

Condition Intervention Phase
Coagulopathy in Patients Having Thoraco-Abdominal Aneurysm Repair
Biological: Fibrinogen concentrate
Biological: Fresh Frozen Plasma
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
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.

Resource links provided by NLM:

Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Pattern of coagulation disturbance in the conventional treatment (FFP) and fibrinogen concentrate groups. [ Time Frame: Inra-operatively, and up to 24 hours post-operatively. ]

Secondary Outcome Measures:
  • Proportion of patients in the fibrinogen group in whom FFP transfusion is required during surgery. [ Time Frame: Operative period. ]
  • Units of FFP transfused - during surgery and up to 24 hours after surgery. [ Time Frame: Peri-operative period. ]
  • Units of platelets and allogeneic red cells transfused - during surgery and up to 24 hours after surgery. [ Time Frame: Peri-operative period. ]
  • Blood loss. [ Time Frame: Operative period. ]

Enrollment: 20
Actual Study Start Date: June 2010
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • Haemocomplettan P
  • ATC code: B02B B01


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Undergoing elective thoracoabdominal aneurysm repair.
  • Over 18 years of age.
  • Able to give written informed consent.

Exclusion Criteria:

  • Previous aortic surgery (re-do surgery).
  • Emergency surgery.
  • Pregnancy.
  • Females of child-bearing age (less than 45 years) not using medically approved method of contraception.
  • Congenital or acquired coagulopathy.
  • Known allergy to study drug.
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Please refer to this study by its identifier: NCT00994045

United Kingdom
The Royal Infirmary of Edinburgh
Edinburgh, United Kingdom, EH16 4SA
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
CSL Behring
Principal Investigator: Alastair Nimmo, MBChB NHS Lothian
  More Information

Responsible Party: Alastair Nimmo, Dr, University of Edinburgh Identifier: NCT00994045     History of Changes
Other Study ID Numbers: FIB692
EudraCT 2009-016709-41
Study First Received: October 13, 2009
Last Updated: January 28, 2017

Keywords provided by University of Edinburgh:
Thoraco-Abdominal Aneurysm (TAAA)
Fresh Frozen Plasma
Fibrinogen Concentrate

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Aortic Aneurysm
Aortic Diseases processed this record on April 27, 2017