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Fibrinogen as an Alternative to FFP in Aortic Surgery.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00994045
Recruitment Status : Completed
First Posted : October 14, 2009
Last Update Posted : January 31, 2017
NHS Lothian
CSL Behring
Information provided by (Responsible Party):
Alastair Nimmo, University of Edinburgh

Brief Summary:

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 or disease Intervention/treatment Phase
Coagulopathy in Patients Having Thoraco-Abdominal Aneurysm Repair Biological: Fibrinogen concentrate Biological: Fresh Frozen Plasma Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Actual Study Start Date : June 2010
Actual Primary Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Fibrinogen

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Proportion of patients in the fibrinogen group in whom FFP transfusion is required during surgery. [ Time Frame: Operative period. ]
  2. Units of FFP transfused - during surgery and up to 24 hours after surgery. [ Time Frame: Peri-operative period. ]
  3. Units of platelets and allogeneic red cells transfused - during surgery and up to 24 hours after surgery. [ Time Frame: Peri-operative period. ]
  4. Blood loss. [ Time Frame: Operative period. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00994045

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

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Responsible Party: Alastair Nimmo, Dr, University of Edinburgh Identifier: NCT00994045     History of Changes
Other Study ID Numbers: FIB692
EudraCT 2009-016709-41
First Posted: October 14, 2009    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Keywords provided by Alastair Nimmo, University of Edinburgh:
Thoraco-Abdominal Aneurysm (TAAA)
Fresh Frozen Plasma
Fibrinogen Concentrate
Additional relevant MeSH terms:
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Hemostatic Disorders
Aortic Aneurysm, Abdominal
Blood Coagulation Disorders
Vascular Diseases
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Aortic Aneurysm
Aortic Diseases