Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2010-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Endovascular Exclusion of Thoracoabdominal And/or Paravisceral Abdominal Aortic Aneurysm
NCT00483249
Abdominal Aortic Aneurysm Surgery and Thrombosis
NCT04325373
Prevention of Endoleaks Using Autologous Platelet Gel on Unruptured Abdominal Aortic Aneurysms
NCT00372138
Follow-up After Endovascular Repair of Abdominal Aortic Aneurysm
NCT00488943
Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System
NCT01348828
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Fresh Frozen Plasma
Fresh Frozen Plasma
Fibrinogen concentrate
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Fresh Frozen Plasma
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Over 18 years of age.
* Able to give written informed consent.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NHS Lothian
OTHER_GOV
CSL Behring
INDUSTRY
University of Edinburgh
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Alastair Nimmo
Dr
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alastair Nimmo, MBChB
Role: PRINCIPAL_INVESTIGATOR
NHS Lothian
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EudraCT 2009-016709-41
Identifier Type: -
Identifier Source: secondary_id
FIB692
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.