Coagulopathy in Patients Having Thoraco-Abdominal Aneurysm RepairPhase 4NCT00994045
Fibrinogen as an Alternative to FFP in Aortic Surgery.
A Phase 4 study testing Fibrinogen concentrate and Fresh Frozen Plasma in people with Coagulopathy in Patients Having Thoraco-Abdominal Aneurysm Repair, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coagulopathy in Patients Having Thoraco-Abdominal Aneurysm Repair
- What is being tested?
- Fibrinogen concentrate and Fresh Frozen Plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2010to Aug 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing elective thoracoabdominal aneurysm repair.
- Over 18 years of age.
- Able to give written informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
About this study
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.
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.
- Being tested
- Fibrinogen concentrate, Fresh Frozen Plasma
- Keywords
- Thoraco-Abdominal Aneurysm (TAAA), Coagulopathy, Fresh Frozen Plasma, Fibrinogen Concentrate
- Medical subject headings
- Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrinogen concentrateBiological
Also called Haemocomplettan P, ATC code: B02B B01
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 PlasmaBiological
| Study group | Role | What they receive |
|---|---|---|
| Fresh Frozen Plasma | Active comparator | Not described Receives: Biological: Fresh Frozen Plasma |
| Fibrinogen concentrate | Experimental | Not described Receives: Biological: Fibrinogen concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pattern of coagulation disturbance in the conventional treatment (FFP) and fibrinogen concentrate groups.
Measured: 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.
Measured: Operative period.
Units of FFP transfused - during surgery and up to 24 hours after surgery.
Measured: Peri-operative period.
Units of platelets and allogeneic red cells transfused - during surgery and up to 24 hours after surgery.
Measured: Peri-operative period.
Blood loss.
Measured: Operative period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startJun 2010
- Primary completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coagulopathy in Patients Having Thoraco-Abdominal Aneurysm RepairStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian, CSL Behring
- Responsible party
- Principal investigator, Alastair Nimmo, University of Edinburgh
- Investigators
- Alastair Nimmo, MBChB, Principal investigator, NHS Lothian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994045
- Sponsor's protocol ID
- FIB692
- Other IDs
- EudraCT 2009-016709-41
- Status last verified
- Jan 2017
- First submitted
- 13 Oct 2009
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00994045
- Acronym / sponsor ID
- FIB692
- Keywords
- Thoraco-Abdominal Aneurysm (TAAA), Coagulopathy, Fresh Frozen Plasma, Fibrinogen Concentrate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian, CSL Behring
- Study start
- Jun 2010 (actual)
- Primary completion
- Aug 2013 (actual)
- First posted
- 14 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fresh Frozen Plasma | Active comparator | Biological: Fresh Frozen Plasma |
| Fibrinogen concentrate | Experimental | Biological: Fibrinogen concentrate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergoing elective thoracoabdominal aneurysm repair.
- Over 18 years of age.
- Able to give written informed consent.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibrinogen concentrateAlso: Haemocomplettan P, ATC code: B02B B01Fibrinogen 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. | Biological | Fibrinogen concentrate |
| Fresh Frozen Plasma | Biological | Fresh Frozen Plasma |
Primary outcome
Pattern of coagulation disturbance in the conventional treatment (FFP) and fibrinogen concentrate groups.
Time frame: Inra-operatively, and up to 24 hours post-operatively.
4 secondary outcomes
Proportion of patients in the fibrinogen group in whom FFP transfusion is required during surgery.
Time frame: Operative period.
Units of FFP transfused - during surgery and up to 24 hours after surgery.
Time frame: 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.
Blood loss.
Time frame: Operative period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alastair Nimmo, MBChB principal investigator
NHS Lothian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fibrinogen concentrate and Fresh Frozen Plasma in people with Coagulopathy in Patients Having Thoraco-Abdominal Aneurysm Repair, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pattern of coagulation disturbance in the conventional treatment (FFP) and fibrinogen concentrate groups. (time frame: Inra-operatively, and up to 24 hours post-operatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2017.