Fibrinogen as an Alternative to FFP in Aortic Surgery.

January 28, 2017 updated by: Alastair Nimmo, University of Edinburgh

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Edinburgh, United Kingdom, EH16 4SA
        • The Royal Infirmary of Edinburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients in the fibrinogen group in whom FFP transfusion is required during surgery.
Time Frame: Operative period.
Operative period.
Units of FFP transfused - during surgery and up to 24 hours after surgery.
Time Frame: Peri-operative period.
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.
Peri-operative period.
Blood loss.
Time Frame: Operative period.
Operative period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

CSL Behring
NHS Lothian

Investigators

  • Principal Investigator: Alastair Nimmo, MBChB, NHS Lothian

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2010

Primary Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

October 13, 2009

First Submitted That Met QC Criteria

October 13, 2009

First Posted (Estimate)

October 14, 2009

Study Record Updates

Last Update Posted (Estimate)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 28, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIB692
  • EudraCT 2009-016709-41

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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