Measurement of ISDs and creatinine by LC-MS/MS in VAMS samples
Research type
Research Study
Full title
Development and validation of method measurement of tacrolimus, ciclosporin, and creatinine in whole blood via 2D turboflow HPLC coupled with tandem mass spectrometry, using VAMS micro sampling techniques.
IRAS ID
302783
Contact name
Zain Odho
Contact email
Sponsor organisation
Guy's and St Thomas' NHS Foundation Trust, Royal Brompton Hospital Research Office
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Patients who receive organ transplants have to take immunosuppressant drugs to stop their immune system rejecting the transplanted organ. These drugs are toxic, particularly to the kidneys, and so the amount patients are given needs to be controlled - enough to be effective, but not enough to be toxic.
The levels of these drugs are measured regularly in transplant patients. This requires conventional blood samples taken via a needle. A new kind of blood collection device (volumetric absorption microsampling tips) has been invented that can be used to collect blood from a fingerprick made with a lancet.
The aim of our study is to investigate whether blood collected in this way can also be used to measure the levels of immunosuppressant drugs in patients. In addition, we also want to see if measure another chemical, called creatinine, can be measured using blood collected in this way; the amount of creatinine in your blood is linked to your how well your kidneys work, and so we hope to be able to check for toxic effects on the kidney at the same time as measuring immunosuppressant drug levels.
If we can show that measurements from the new blood collection device are comparable to those from conventional blood samples, patients will be able to use these devices instead, meaning they can collect these less invasive samples themselves at home, without having to travel or rely on phlebotomist time.
A similar project to this was done in Manchester, where they showed that measurements of one particular drug (ciclosporin) and creatinine taken using the new devices were similar to conventional blood samples. We want to measure other drugs as well (tacrolimus, sirolimus), and do a set of experiments to demonstrate the method is safe to use in patients and gain regulatory accreditation.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
21/PR/1599
Date of REC Opinion
6 Dec 2021
REC opinion
Favourable Opinion