Ignite Creation Date:
2024-05-06 @ 6:23 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05647096
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-29
First Post:
2022-12-03
Brief Title:
Safety Tolerability and Performance of the NucleoCapture Device in the Reduction of Circulating cfDNANETs in Subjects With Sepsis
Sponsor:
Santersus AG
Organization:
Santersus AG
Study Overview
Official Title:
Safety Tolerability and Performance of the NucleoCapture Extracorporeal Therapeutic Apheresis Device in the Reduction of Circulating cfDNANETs in Subjects With Sepsis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
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:
NUC-CAP
Brief Summary:
This is a prospective multinational multicentre randomised parallel-group open-label 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 sepsis patients
Detailed Description:
This study investigates the safety tolerability and performance of the NucleoCapture extracorporeal apheresis device in patients with sepsis and respiratory failure Sepsis is a common condition in hospital settings and is associated with high rates of morbidity and mortality and despite ongoing development in the treatment and supportive care of sepsis mortality remains considerable
cfDNANET therapeutic apheresis with NucleoCapture is indicated for the treatment of sepsis and for the treatmentprevention of septic shock Participants will be randomised to receive either standard of care SOC or SOC plus NucleoCapture treatment SOC will be according to the current guidelines described by the Surviving Sepsis Campaign international guidelines for the management of sepsis and septic shock 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 and tests will take place for all participants whilst in Intensive Care Unit ICU on days 1 to 5 day 7 day 14 day 21 and day 28 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
cfDNANET therapeutic apheresis with NucleoCapture is indicated for the treatment of sepsis and for the treatmentprevention of septic shock Participants will be randomised to receive either standard of care SOC or SOC plus NucleoCapture treatment SOC will be according to the current guidelines described by the Surviving Sepsis Campaign international guidelines for the management of sepsis and septic shock 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 and tests will take place for all participants whilst in Intensive Care Unit ICU on days 1 to 5 day 7 day 14 day 21 and day 28 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
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