The objective of the PK/PD element of ESETT is to relate drug exposure with seizure cessation and the key secondary outcomes per the ESETT protocol. To accomplish this objective, 2 blood samples are collected within the framework of the ESETT protocol, one between 20 and 50 minutes and a second between 60 and 120 minutes, from the start of study drug infusion. Click on the links below for more information.
Manual of Procedures (Section 21)
To complete the training requirement do any one of the following: view the training slides below, watch the video below, attend a group training provided by your study team, OR attend a group training session provided by the clinical coordinating center.
*ATTN: PI or Primary Study Coordinator please complete the PK/PD Attestation of Training below once you completed the training (individually or as a group), then upload it to WebDCU.
Q. Can a blood sample drawn from the drug infusion site be used?
A. No. Studies have shown that even with multiple flushing steps, drug concentrations are very often artificially high in such samples. If blood is inadvertently drawn from the drug infusion site, please discard sample and record in the PK blood collection eCRF. While this is a procedural deviation, it is NOT a protocol deviation.
Q. Can blood drawn from a site used to deliver fluids or other study medication be used?
A. Yes. Blood can be drawn from any site NOT used for study drug infusion.
Q. What should I do if we collect only one blood sample?
A. Process and ship the sample as specified. While we expect to obtain 2 samples from most subjects, a single sample from a subset of patients will still be valuable. This is NOT a protocol deviation.
Q. What should I do if we obtain the blood sample outside of the sampling time window?
A. The data from this sample can still be used. Record the actual time that the sample was collected on the PK blood collection eCRF and process and ship that sample as specified. While this is a procedural deviation, it is NOT a protocol deviation.
Q. What should I do if the blood sample is centrifuged greater than 2 hrs after sample collection?
A. Record the procedural deviation under Question 8 of the PK blood collection eCRF. This is NOT a protocol deviation.
Q. What should I do if the volume of blood collected is less than 2.5 - 3 mL?
A. The sample will still be used. Process and ship the sample as specified. This is NOT a protocol deviation.
Q. What happens if I have misplaced or damaged the sample kit?
A. If pre-labeled vacutainer tubes or cryogenic vials are not available, you can use an EDTA-containing (lavender top) vacutainer tube for blood collection and a cryogenic vial or Eppendorf tube for the plasma sample available at your site. Tubes and vials should be labeled as specified in the Manual of Procedures.