Blood Loss, Postoperative, Blood Loss, Surgical, Hemorrhage Postoperative, Hemorrhage, Surgical
Conditions
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.
Interventions
DEVICECytoSorb
Sorbent hemoperfusion system
Sponsors
CytoSorbents, Inc
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* CytoSorb utilization for antithrombotic removal * Informed consent for prospective registry participation
Exclusion criteria
• Use of CytoSorb for purpose other than antithrombotic removal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bleeding complications including requirements for transfusions and other blood products | Assessed until postoperative day (POD) 3, date of ICU discharge, or date of death, whatever comes first; on average 3 days |
Countries
Austria, Belgium, Germany, Sweden, Switzerland, United Kingdom
Contacts
Primary ContactCindy Rechner, PhD
Backup ContactRobert Wilke
Outcome results
None listed