Bleeding, Drug Removal, Emergent Cardiothoracic Surgery
Conditions
Brief summary
TISORB is a study to show that the CytoSorb device removes ticagrelor from blood during surgery in patients who need emergency surgery on their heart. The hypothesis of TISORB is that removal of ticagrelor by the CytoSorb device during surgery will decrease the risk for surgical bleeding from ticagrelor.
Interventions
DEVICECytoSorb 300 mL device
Intra-operative CytoSorb hemoadsorption of ticagrelor during cardiopulmonary bypass
Sponsors
CytoSorbents, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, open, multi-center, single arm study
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Cardiothoracic surgery requiring cardiopulmonary bypass ≤ 48 hours following the last dose of ticagrelor.
Exclusion criteria
Any cardiothoracic surgery \> 48 hours after last dose of ticagrelor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Pharmacodynamic Endpoint | Immediately before and after cardiopulmonary bypass | Change in platelet reactivity as measured by ADPtest on the Multiplate Analyzer immediately before and after cardiopulmonary bypass. The unit of measure is Aggregation Units (AU). |
| Primary Pharmacokinetic Endpoint | Immediately before and after cardiopulmonary bypass | Percent change in ticagrelor blood concentration immediately before and after cardiopulmonary bypass. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CytoSorb 300 mL Device Treatment Population Single arm | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | CytoSorb 300 mL Device Treatment Population |
|---|---|
| Age, Continuous | 69 years STANDARD_DEVIATION 11.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United Kingdom | 5 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 5 Participants |
| Study patient with last dose of Ticagrelor within 48 hours of surgery | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 3 / 5 |
Outcome results
Primary
Primary Pharmacodynamic Endpoint
Change in platelet reactivity as measured by ADPtest on the Multiplate Analyzer immediately before and after cardiopulmonary bypass. The unit of measure is Aggregation Units (AU).
Time frame: Immediately before and after cardiopulmonary bypass
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CytoSorb 300 mL Device Treatment Population | Primary Pharmacodynamic Endpoint | 7 Aggregation Units (AU) | Standard Deviation 8 |
Primary
Primary Pharmacokinetic Endpoint
Percent change in ticagrelor blood concentration immediately before and after cardiopulmonary bypass.
Time frame: Immediately before and after cardiopulmonary bypass
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CytoSorb 300 mL Device Treatment Population | Primary Pharmacokinetic Endpoint | 63 Percent change | Standard Deviation 12 |