Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06566638
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Safety Tolerability and Performance of the NucleoCapture Extracorporeal Therapeutic Apheresis Device in the Reduction of Circulating cfDNANETs in Subjects With Pancreatitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety Tolerability and Performance of the NucleoCapture Extracorporeal Therapeutic Apheresis Device in the Reduction of Circulating cfDNANETs in Subjects With Pancreatitis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NUC-SAP
Brief Summary:
This is a single-centre randomised-controlled open-label feasibility study to assess the safety tolerability and performance of the NucleoCapture extracorporeal apheresis device in the reduction of circulating cell-free DNA cfDNANeutrophil Extracellular Traps NETs in patients with severe acute pancreatitis
Detailed Description:
This study investigates the safety tolerability and performance of the NucleoCapture extracorporeal apheresis device in patients with acute pancreatitis Acute pancreatitis is one of the leading gastrointestinal disorders that require urgent clinical care and is increasing in incidence
cfDNANET therapeutic apheresis with NucleoCapture is indicated for the treatment of diseases in which excessive levels of cfDNANETs are found such as acute pancreatitis Participants will be randomised to receive either standard of care SOC alone or SOC plus NucleoCapture treatment SOC will be according to the current guidelines described by the European Society of Intensive Medicine ESICM Participants in the SOC plus NucleoCapture arm will receive one treatment session with NucleoCapture per day for the first three days Each treatment session with NucleoCapture will last for up 6 hours aiming to treat 45 plasma volumes Treatment sessions with NucleoCapture treating less than 35 plasma volumes will be counted as incomplete and the treatment session will be repeated on the following day up to day 5 maximum
Assessments will take place for all participants whilst in the Intensive Care Unit ICU on days 1 to 5 7 14 21 and 28 and at 90 days post discharge to ward-based care Participants transferred to ward-based care before day 28 will receive no further study assessment visits from the point of transfer to ward-based care apart from day 28 in which participants will receive a final study assessment visit and a patient reported outcome assessment PROM 90 days post discharge to ward-based care
cfDNANET therapeutic apheresis with NucleoCapture is indicated for the treatment of diseases in which excessive levels of cfDNANETs are found such as acute pancreatitis Participants will be randomised to receive either standard of care SOC alone or SOC plus NucleoCapture treatment SOC will be according to the current guidelines described by the European Society of Intensive Medicine ESICM Participants in the SOC plus NucleoCapture arm will receive one treatment session with NucleoCapture per day for the first three days Each treatment session with NucleoCapture will last for up 6 hours aiming to treat 45 plasma volumes Treatment sessions with NucleoCapture treating less than 35 plasma volumes will be counted as incomplete and the treatment session will be repeated on the following day up to day 5 maximum
Assessments will take place for all participants whilst in the Intensive Care Unit ICU on days 1 to 5 7 14 21 and 28 and at 90 days post discharge to ward-based care Participants transferred to ward-based care before day 28 will receive no further study assessment visits from the point of transfer to ward-based care apart from day 28 in which participants will receive a final study assessment visit and a patient reported outcome assessment PROM 90 days post discharge to ward-based care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None