Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421792
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-04-21
Brief Title:
PrOtamIne doSing clOt imagiNg POISON Study
Sponsor:
Papworth Hospital NHS Foundation Trust
Organization:
Papworth Hospital NHS Foundation Trust
Study Overview
Official Title:
Scanning Electron Microscopy SEM and Confocal Imaging of Clot in Two Different Protamine Environments PrOtamIne doSing clOt imagiNg POISON Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POISON
Brief Summary:
The proposed study involves using two different high-resolution microscopic imaging techniques to examine the health and platelet invasion of clot in patients who were given 11 protamine heparin and compare this to clot from patients who had heparin reversed using the PRODOSE algorithm Patients will be treated according to the routine clinical practice of their individual care team
Detailed Description:
Sample collection at RPH
Patients will have a total of 14ml of blood taken during the procedure
The first 7ml will be taken after induction of anaesthesia along with routine blood gas and coagulation sampling through the routinely indwelling arterial catheter The initial sample must be taken before any heparin has been administered This will be used to fill 2 x 35ml citrated green top blood tubes These will be clearly labelled as pre-heparin with a Tissue Bank ID number
The second 7ml will be taken 5 minutes after heparin has been reversed with protamine after cessation of cardiopulmonary bypass It will again be taken at the same time as routine sampling for blood gas and coagulation studies Analog to the first sample it will again be divided and used to fill 2 x 35ml citrated green top blood tubes These will be clearly labelled as post-protamine with the same ID number and whether 11 or a PRODOSE algorithm determined protamine heparin ratio was used
In keeping with clinical routine ROTEM coagulation testing and full blood counts will be requested as seen necessary by the clinical team
The samples will be sent to Royal Papworth Hospital RPH Tissue Bank for initial processing Samples need to be processed within 4 hours of blood draw
After initial processing samples will be sent for confocal imaging to the MRC Laboratory of Molecular Biology LMB and for SEM imaging to the University of Oxford respectively
Clinical data to be collected to be completed by anaesthetic team
1 Demographic information Age Gender Weight Height Medication history
2 Type of surgery
3 Cardiac drug history and antiplatelets anticoagulants and timing
4 Coagulation tests ACT ROTEM at the following points a Pre-heparin b Post-heparin pre-CPB c Throughout CPB c Post-protamine
5 Full blood count at the following points a Pre-surgery and date of sample b Post-protamine 6 CPB and x-clamp times nadir temperature
Patients will have a total of 14ml of blood taken during the procedure
The first 7ml will be taken after induction of anaesthesia along with routine blood gas and coagulation sampling through the routinely indwelling arterial catheter The initial sample must be taken before any heparin has been administered This will be used to fill 2 x 35ml citrated green top blood tubes These will be clearly labelled as pre-heparin with a Tissue Bank ID number
The second 7ml will be taken 5 minutes after heparin has been reversed with protamine after cessation of cardiopulmonary bypass It will again be taken at the same time as routine sampling for blood gas and coagulation studies Analog to the first sample it will again be divided and used to fill 2 x 35ml citrated green top blood tubes These will be clearly labelled as post-protamine with the same ID number and whether 11 or a PRODOSE algorithm determined protamine heparin ratio was used
In keeping with clinical routine ROTEM coagulation testing and full blood counts will be requested as seen necessary by the clinical team
The samples will be sent to Royal Papworth Hospital RPH Tissue Bank for initial processing Samples need to be processed within 4 hours of blood draw
After initial processing samples will be sent for confocal imaging to the MRC Laboratory of Molecular Biology LMB and for SEM imaging to the University of Oxford respectively
Clinical data to be collected to be completed by anaesthetic team
1 Demographic information Age Gender Weight Height Medication history
2 Type of surgery
3 Cardiac drug history and antiplatelets anticoagulants and timing
4 Coagulation tests ACT ROTEM at the following points a Pre-heparin b Post-heparin pre-CPB c Throughout CPB c Post-protamine
5 Full blood count at the following points a Pre-surgery and date of sample b Post-protamine 6 CPB and x-clamp times nadir temperature
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None