Fibrinogen as an Alternative to FFP in Aortic Surgery.
Recruitment status was Not yet recruiting
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Purpose
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 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 ]
| Estimated Enrollment: | 20 |
| 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:
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| Contact: Alastair Nimmo, MBChB | 0131 242 3224 ext 23222 | a.nimmo@ed.ac.uk |
| Contact: Gary A Morrison, MBChB | 0131 242 3224 ext 23229 | gary.morrison@luht.scot.nhs.uk |
| United Kingdom | |
| The Royal Infirmary of Edinburgh | Not yet recruiting |
| Edinburgh, United Kingdom, EH16 4SA | |
| Principal Investigator: | Alastair Nimmo, MBChB | NHS Lothian |
More Information
No publications provided
| Responsible Party: | Dr Alastair Nimmo, NHS Lothian |
| ClinicalTrials.gov Identifier: | NCT00994045 History of Changes |
| Other Study ID Numbers: | FIB692, EudraCT 2009-016709-41 |
| Study First Received: | October 13, 2009 |
| Last Updated: | April 7, 2010 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: Research Ethics Committee United Kingdom: National Health Service |
Keywords provided by University of Edinburgh:
|
Thoraco-Abdominal Aneurysm (TAAA) Coagulopathy Fresh Frozen Plasma Fibrinogen Concentrate |
Additional relevant MeSH terms:
|
Aneurysm Blood Coagulation Disorders Hemostatic Disorders Aortic Aneurysm, Abdominal Aortic Aneurysm, Thoracic Vascular Diseases |
Cardiovascular Diseases Hematologic Diseases Hemorrhagic Disorders Aortic Aneurysm Aortic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013