FIBCON: Fibrinogen concentrate in paediatric cardiopulmonary bypass
Research type
Research Study
Full title
Fibrinogen concentrate supplementation in the management of bleeding during paediatric cardiopulmonary bypass: a phase 1B/2A, open label dose escalation study (Version 1.0, Jan 28, 2014)
IRAS ID
145375
Contact name
Shane Tibby
Contact email
Sponsor organisation
Guy's & St Thomas' NHS Foundation Trust
Eudract number
2013-003532-68
Research summary
Neonates and infants who require cardiopulmonary bypass surgery for congenital heart disease have a high incidence of post-operative mediastinal bleeding (bleeding within the chest). As a consequence, they are frequently exposed to many blood products, and may also suffer consequences of blood loss. We aim to evaluate the targeted, intra-operative administration of a new blood product, human fibrinogen concentrate, to these infants, with the ultimate aim of both reducing bleeding and exposure to other blood products. This study will be an early phase trial (1B/2A), providing dose finding, safety and preliminary efficacy data.
A unique aspect of this trial will be the targeted nature of administration, whereby study drug exposure and dose will be individualised to the patient, on the basis of bleeding risk. Because bleeding risk cannot be estimated accurately before the operation, we will assess this during the operation using a point of care test for coagulation, known as rotational thromboelastometry (ROTEM). Study drug exposure will only occur for infants who are deemed at higher risk of bleeding during intraoperative ROTEM screening; these infants will be randomised to fibrinogen:placebo in a 2:1 ratio. Infants at lower risk will not be randomised, but remain in the study, forming an observational cohort. All infants will receive standard care for all other aspects (including administration of other blood products as clinically indicated).
REC name
London - London Bridge Research Ethics Committee
REC reference
14/LO/0267
Date of REC Opinion
11 Mar 2014
REC opinion
Favourable Opinion