Fibrinogen as an Alternative to FFP in Aortic Surgery.
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.
2 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2009
CompletedFirst Posted
Study publicly available on registry
October 14, 2009
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedJanuary 31, 2017
January 1, 2017
3.2 years
October 13, 2009
January 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pattern of coagulation disturbance in the conventional treatment (FFP) and fibrinogen concentrate groups.
Inra-operatively, and up to 24 hours post-operatively.
Secondary Outcomes (4)
Proportion of patients in the fibrinogen group in whom FFP transfusion is required during surgery.
Operative period.
Units of FFP transfused - during surgery and up to 24 hours after surgery.
Peri-operative period.
Units of platelets and allogeneic red cells transfused - during surgery and up to 24 hours after surgery.
Peri-operative period.
Blood loss.
Operative period.
Study Arms (2)
Fresh Frozen Plasma
ACTIVE COMPARATORFibrinogen concentrate
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Undergoing elective thoracoabdominal aneurysm repair.
- Over 18 years of age.
- Able to give written informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Edinburghlead
- NHS Lothiancollaborator
- CSL Behringcollaborator
Study Sites (1)
The Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alastair Nimmo, MBChB
NHS Lothian
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
October 13, 2009
First Posted
October 14, 2009
Study Start
June 1, 2010
Primary Completion
August 1, 2013
Last Updated
January 31, 2017
Record last verified: 2017-01