Assessment of DOAC therapy analysis at TGH (Version 1).
Research type
Research Study
Full title
An investigation into the efficacy of the Sysmex CS2100i coagulation reagents and test assays for use in assessment of cardiology patients commenced on Direct Oral Anti-Coagulants (DOACs) at Tameside General Hospital (TGH) Foundation Trust.
IRAS ID
204352
Contact name
Gillian Lewis
Contact email
Sponsor organisation
Tameside General NHS Foundation Trust
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 2 months, 30 days
Research summary
INTRODUCTION: The effect of newly approved Direct Oral Anti-Coagulant agents or ‘DOACs’ on routine coagulation assays, namely the PT/INR, APTT and Fibrinogen in addition to specialised laboratory assays; is an inadequately researched topic. Efficacy of these clotting assays and their corresponding reagents currently in use in the coagulation department at Tameside Hospital is unknown in relation to DOAC assessment.
AIM: The aim of this project is to initially implement two new calibrated assays, namely the Thrombin Time and anti-Factor Xa assay not currently in use, to enable in-house analysis. In so doing, the determination of whether correlation is observed between the routine methods in practice (PT/APTT/Fibrinogen); and whether an appropriate reference range can be established for the specialised assays introduced; observed specifically in newly commenced DOAC cardiology patient groups.
METHODS: Patient citrate samples will be collected, specifically from a negative control group (normal plasma), positive control group (patients on Warfarin) and cardiology patients who have recently been commenced on a DOAC therapy that make up the study group. Once received, these samples will be analysed in-house for routine coagulation screen and the relevant clinical assay on the Sysmex CS2100i analyser.
RESULTS: Successful investigation of assay/reagent testing efficacy will result in the execution of DOAC status assessment quantitatively; in the newly commenced cardiology patient, approximately two weeks post initiation of treatment at Tameside General Hospital Foundation Trust.REC name
North East - York Research Ethics Committee
REC reference
16/NE/0290
Date of REC Opinion
23 Aug 2016
REC opinion
Favourable Opinion