Ignite Creation Date:
2024-05-06 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 2:15 PM
Study NCT ID:
NCT05077124
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2021-09-09
Brief Title:
Safe and Timely Antithrombotic Removal STAR Registry
Sponsor:
CytoSorbents Inc
Organization:
CytoSorbents Inc
Study Overview
Official Title:
Safe and Timely Antithrombotic Removal STAR Registry International Registry on the Use of CytoSorb for Removal of Antithrombotic Agents in the Acute Hospital Setting
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
This registry will capture real-world clinical use patterns and associated clinical outcomes with the use of CytoSorb for the removal of antithrombotic agents
Detailed Description:
The STAR Registry will collect patient-level clinical data on antithrombotic removal with CytoSorb The decision to use CytoSorb in this clinical setting is based on the clinical rationale of mitigating the high risk of bleeding events that is directly linked to the presence of the antithrombotic agent This registry is to capture real-world clinical use patterns and associated clinical outcomes with the use of CytoSorb Data of retrospective and prospective patients will be included in the registry Safety will be assessed by collection of at least possibly device-related adverse events Data collection is done up to 30 days post-operation
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