Comparison of Octaplas VS FFP in paediatric cardiac surgical patients
Research type
Research Study
Full title
Comparison of the coagulation effect acheived by Octaplas versus Fresh Frozen Plamsa in paediatric cardiac surgical patients
IRAS ID
167455
Contact name
Aman Kalsi
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Duration of Study in the UK
0 years, 2 months, 1 days
Research summary
Octaplas® (a commercially available and licensed product for the management of bleeding) was introduced into common use at University Hospital Southampton (UHS) on 01/07/2007. Since then, it has been used in place of Fresh Frozen Plasma (FFP) when replacing coagulation factors in the paediatric cardiac surgical patients.
Octaplas® is indicated for use in patients undergoing cardiac surgery who require replacement of multiple clotting factors. The use of Octaplas® over single donor Fresh Frozen Plasma (FFP) may have beneficial effects when considering transmission of enveloped viruses. However, its efficacy and safety has not yet been evaluated in the paediatric population.We wish to collect retrospective data on a specific operative subgroup of children that have undergone heart surgery for a single congenital heart defect {i.e. Tetralogy of Fallot (TOF)} with the aim of comparing the efficacy, coagulation effect achieved and safety of Octaplas® versus FFP.
We will identify appropriate patients from 2002 – 2012 from an existing clinical database, that have had TOF repairs as their primary procedure within 2 years of their birth. The investigators are all members of the clinical team at UHS and have existing access to this database for clinical and audit purposes. Once potential patients have been identified from the database by the clinical team then, we will extract the relevant clinical notes and review these to obtain the data required for our project.
We will comply with the Data Protection Act and all relevant Trust policies. All data extracted will be link anonymised to protect patient identity and will be held within the UHS facilities either on Trust computers, or in the case of paper copies will be held within a locked cabinet. We will ensure that final data set for analysis will have all of the patient identifiable data removed.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
15/SW/0099
Date of REC Opinion
8 May 2015
REC opinion
Favourable Opinion