Haemostatic Changes during Therapeutic Plasma Exchange (TPE)
Research type
Research Study
Full title
The Impact of Different Replacement Fluids during Therapeutic Plasma Exchange (TPE) on Haemostatic Parameters
IRAS ID
247935
Contact name
Ruchika Kohli
Contact email
Sponsor organisation
Queen Mary University of London
Duration of Study in the UK
1 years, 0 months, 4 days
Research summary
Therapeutic Plasma Exchange (TPE) is an automated procedure, which involves the targeted removal of circulating plasma containing auto or alloantibodies, immune complexes and paraproteins and replacing these with a volume replacement fluid such as plasma, colloid, crystalloid or a combination.
The main factors for choosing a replacement fluid during TPE are dependent on availability of the fluid type, patient’s baseline albumin level, coagulation profile, bleeding risk and the underlying disease condition.
Guidelines on choice of replacement fluid used during TPE lack strong scientific evidence base, are non-specific and vary between countries.
Practice across different apheresis units varies according to local expertise, availability of certain replacement fluids and cost implications.
We will study four groups of patients across three different study sites.
The first three groups will include patients at low bleeding risk who will receive different fluid replacement regimens as per their local hospital guidelines. We will compare changes in clotting factors before and after each TPE session for the duration of their treatment.
The fourth group will consist of patients who are at moderate/high risk of bleeding and receive plasma as part of their fluid replacement and we will compare changes in their clotting factors before and after each TPE session for the duration of treatment.
We aim to recruit 120 patients deemed eligible by their direct clinical care team across the four groups. Permission to take additional blood samples (not exceeding 15mls)for further evaluation of their clotting system will be sought. These blood samples will be taken at the same time as routine samples, where possible, therefore not requiring additional needles.
Patient management will not change as a result of this study but data generated will provide the framework upon which a future randomized controlled trial will be designed that will compare the efficacy and safety of different replacement fluids used during TPE procedures.
REC name
London - Riverside Research Ethics Committee
REC reference
18/LO/1954
Date of REC Opinion
1 Nov 2018
REC opinion
Favourable Opinion