Stability of Antiepileptics in Serum and K2 EDTA Plasma samples

• Research type

  Research Study

• Full title

  Stability of Antiepileptics in Serum and K2 EDTA Plasma Patient Samples In Cascadion™ SM Antiepileptics

• IRAS ID

  310607

• Contact name

  Ley Sander

• Contact email

  ley.sander@nhs.net

• Sponsor organisation

  Thermo Fisher Scientific Oy

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  0 years, 6 months, 0 days

• Research summary

  This is a profit, multi-center, prospective, observational post-market evaluation study. The aim of this study is to evaluate the stability of the antiepileptic analytes measured with Cascadion™ SM Antiepileptics, an in vitro diagnostic device intended for clinical laboratory use only, in serum and K2 EDTA samples of patients who use at least one antiepileptics. Serum and K2 EDTA samples of patients will be collected, processed and subjected to various storage conditions or freeze-thaw cycles that represent common sample handling conditions in the commercial clinical laboratory setting. Results of this study will be used to define the claim for the storage conditions for whole blood samples containing the analytes of interest. Eligible subjects sign the ICF and go through one venous sampling for about 20-25 mL of whole blood.

  Inclusion Criteria:
  1. Age ≥18 years
  2. Ability to sign informed consent form
  3. Patients using at least one of the following antiepileptics drugs:
  a. Brivaracetam, Carbamazepine, Clobazam, Clonazepam, Diazepam, Eslicarbazepine, Felbamate, Gabapentin, Lacosamide, Lamotrigine, Levetiracetam, Nordiazepam, Oxcarbazepine, Perampanel, Pregabalin, Rufinamide, Stiripentol, Sulthiame, Tiagabine, Topiramate, Zonisamide.

  Exclusion Criteria
  1. Inability to provide informed consent
  2. Pregnancy or breastfeeding
  3. Likely to believe that the sample collection procedure will pose an unusually high risk for subject’s physical or mental health or their comfort

  Expected recruitment time is 3-5 months. Testing of the samples will continue additional two months after the last patient has been enrolled. Estimated starting time is March 2022.
  Subject may withdraw from the study at any time and for any reason. This decision will have no effect on future treatments and will not incur any penalty or prejudice.
  

• REC name

  South East Scotland REC 02

• REC reference

  22/SS/0032

• Date of REC Opinion

  31 May 2022

• REC opinion

  Further Information Favourable Opinion