Coagulopathy in Patients Having Thoraco-Abdominal Aneurysm Repair Clinical Trial
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.
| Verified date | January 2017 |
| Source | University of Edinburgh |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | |
| Est. primary completion date | August 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | The Royal Infirmary of Edinburgh | Edinburgh |
| Lead Sponsor | Collaborator |
|---|---|
| University of Edinburgh | CSL Behring, NHS Lothian |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pattern of coagulation disturbance in the conventional treatment (FFP) and fibrinogen concentrate groups. | Inra-operatively, and up to 24 hours post-operatively. | ||
| Secondary | Proportion of patients in the fibrinogen group in whom FFP transfusion is required during surgery. | Operative period. | ||
| Secondary | Units of FFP transfused - during surgery and up to 24 hours after surgery. | Peri-operative period. | ||
| Secondary | Units of platelets and allogeneic red cells transfused - during surgery and up to 24 hours after surgery. | Peri-operative period. | ||
| Secondary | Blood loss. | Operative period. |