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| ID | Type | Description | Link |
|---|---|---|---|
| IRAS project ID 264064 | Other Identifier | UK Integrated Research Approval System (IRAS) |
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Stalled study execution from the impact of the COVID-19 pandemic on the UK NHS
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacodynamic population | Experimental | Single arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CytoSorb 300 mL device | Device | Intra-operative CytoSorb hemoadsorption of ticagrelor during cardiopulmonary bypass |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Immediately before and after cardiopulmonary bypass |
| Primary Pharmacokinetic Endpoint | Percent change in ticagrelor blood concentration immediately before and after cardiopulmonary bypass. | Immediately before and after cardiopulmonary bypass |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Tom Clutton-Brock, MB, ChB | NIHR Trauma Management, MedTech Cooperative | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth Hospital | Birmingham | England | B15 2TH | United Kingdom | ||
| Blackpool Victoria Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | CytoSorb 300 mL Device Treatment Population | Single arm |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CytoSorb 300 mL Device Treatment Population | Single arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | Aggregation Units (AU) | Immediately before and after cardiopulmonary bypass |
|
|
Up to 30 days after surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CytoSorb 300 mL Device Treatment Population | Single arm | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CytoSorbents | CytoSorbents | 732-329-8885 | info@cytosorbents.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 11, 2019 | Feb 11, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Prospective, open, multi-center, single arm study
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| Blackpool |
| England |
| FY3 8NR |
| United Kingdom |
| Harefield Hospital | Harefield | England | UB9 6JH | United Kingdom |
| Manchester Royal Infirmary | Manchester | England | M13 9WL | United Kingdom |
| Northern General Hospital | Sheffield | England | S5 7AU | United Kingdom |
| Aberdeen Royal Infirmary | Aberdeen | Scotland | AB25 2ZN | United Kingdom |
| Royal Infirmary of Edinburgh | Edinburgh | Scotland | EH16 4SA | United Kingdom |
| Golden Jubilee National Hospital | Glasgow | Scotland | G81 4DY | United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Study patient with last dose of Ticagrelor within 48 hours of surgery | Count of Participants | Participants |
|
|
| Primary | Primary Pharmacokinetic Endpoint | Percent change in ticagrelor blood concentration immediately before and after cardiopulmonary bypass. | Posted | Mean | Standard Deviation | Percent change | Immediately before and after cardiopulmonary bypass |
|
|
|
| 5 |
| 3 |
| 5 |
| 0 |
| 5 |
| Cardiopulmonary failure | Cardiac disorders | Systematic Assessment |
|
| Pulmonary embolus | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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