Not provided
Not provided
Not provided
Not provided
Due to Corona pandemic, planned ammount of enrolled patient could not be reached, protocol section "Early termination of the study" - criterion "Difficulties in recruiting patients" is fully met->recruitment period will not be extended
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of CyTation is to demonstrate intra-operative removal of ticagrelor by CytoSorb® hemadsorption in patients on ticagrelor undergoing emergent cardiothoracic surgery requiring CPB, using platelet reactivity to adenosine diphosphate (ADP) as a pharmacodynamics surrogate measure of ticagrelor levels in blood.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients on ticagrelor undergoing emergent cardiothoracic surgery requiring CPB | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling and analysis | Procedure | Blood sampling for pharmacokinetics (Plasma ticagrelor concentrations and its metabolite) and MEA platform testing (ADPtest, TRAPtest) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Platelet reactivity | Proportion of patients with post-operative platelet reactivity to ADP above the level associated with increased bleeding risk (≥ 22 ADP-induced platelet aggregation units (AUC in units)) measured on the MEA platform immediately after CPB compared to immediately before CPB. | 8 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kambiz Hassan, M.D. | Asklepios Kliniken Hamburg gGmbH, Asklepios Klinik St. Georg, Abteilung für Herzchirurgie/ Chefarzt Prof. Michael Schmoeckel, Lohmühlenstr. 5, 20099 Hamburg/Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Essen | Essen | 45147 | Germany | |||
| Asklepios Hospital St. Georg Hamburg |
Not provided
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Hamburg |
| 20099 |
| Germany |
| University Hospital Jena | Jena | 07747 | Germany |
| Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle | Luxembourg | 1210 | Luxembourg |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |