TISORB: Ticagrelor CytoSorb Hemoadsorption
Sponsor
CytoSorbents, Inc (Industry)
Overall Status
Terminated
CT.gov ID
NCT04131959
Collaborator
(none)
5
8
1
18.2
0.6
0
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
5 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective, open, multi-center, single arm studyProspective, open, multi-center, single arm study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Ticagrelor CytoSorb Hemoadsorption (TISORB): Prospective, Open, Multi-center, Single-arm Study to Demonstrate the Feasibility of the CytoSorb® 300 mL Device to Remove Ticagrelor During Cardiopulmonary Bypass in Patients on Ticagrelor Undergoing Emergent or Urgent Cardiothoracic Surgery
Actual Study Start Date
:
Oct 29, 2019
Actual Primary Completion Date
:
May 4, 2021
Actual Study Completion Date
:
May 4, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pharmacodynamic population Single arm |
Device: CytoSorb 300 mL device
Intra-operative CytoSorb hemoadsorption of ticagrelor during cardiopulmonary bypass
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Queen Elizabeth Hospital | Birmingham | England | United Kingdom | B15 2TH |
| 2 | Blackpool Victoria Hospital | Blackpool | England | United Kingdom | FY3 8NR |
| 3 | Harefield Hospital | Harefield | England | United Kingdom | UB9 6JH |
| 4 | Manchester Royal Infirmary | Manchester | England | United Kingdom | M13 9WL |
| 5 | Northern General Hospital | Sheffield | England | United Kingdom | S5 7AU |
| 6 | Aberdeen Royal Infirmary | Aberdeen | Scotland | United Kingdom | AB25 2ZN |
| 7 | Royal Infirmary of Edinburgh | Edinburgh | Scotland | United Kingdom | EH16 4SA |
| 8 | Golden Jubilee National Hospital | Glasgow | Scotland | United Kingdom | G81 4DY |
Sponsors and Collaborators
- CytoSorbents, Inc
Investigators
- Principal Investigator: Tom Clutton-Brock, MB, ChB, NIHR Trauma Management, MedTech Cooperative
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
CytoSorbents, Inc
ClinicalTrials.gov Identifier:
NCT04131959
Other Study ID Numbers:
- 2018-002
- IRAS project ID 264064
First Posted:
Oct 18, 2019
Last Update Posted:
Mar 9, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | CytoSorb 300 mL Device Treatment Population |
|---|---|
| Arm/Group Description | Single arm |
| Period Title: Overall Study | |
| STARTED | 5 |
| COMPLETED | 5 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | CytoSorb 300 mL Device Treatment Population |
|---|---|
| Arm/Group Description | Single arm |
| Overall Participants | 5 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
69
(11.2)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
0
0%
|
| Male |
5
100%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
5
100%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (Count of Participants) | |
| United Kingdom |
5
100%
|
| Study patient with last dose of Ticagrelor within 48 hours of surgery (Count of Participants) | |
| Count of Participants [Participants] |
5
100%
|
Outcome Measures
| Title | Primary Pharmacodynamic Endpoint |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | CytoSorb 300 mL Device Treatment Population |
|---|---|
| Arm/Group Description | Single arm |
| Measure Participants | 5 |
| Mean (Standard Deviation) [Aggregation Units (AU)] |
7
(8)
|
| Title | Primary Pharmacokinetic Endpoint |
|---|---|
| Description | Percent change in ticagrelor blood concentration immediately before and after cardiopulmonary bypass. |
| Time Frame | Immediately before and after cardiopulmonary bypass |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Pharmacodynamic Population |
|---|---|
| Arm/Group Description | Single arm |
| Measure Participants | 5 |
| Mean (Standard Deviation) [Percent change] |
63
(12)
|
Adverse Events
| Time Frame | Up to 30 days after surgery | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | CytoSorb 300 mL Device Treatment Population | |
| Arm/Group Description | Single arm | |
All Cause Mortality |
||
| CytoSorb 300 mL Device Treatment Population | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/5 (40%) | |
Serious Adverse Events |
||
| CytoSorb 300 mL Device Treatment Population | ||
| Affected / at Risk (%) | # Events | |
| Total | 3/5 (60%) | |
| Cardiac disorders | ||
| Cardiopulmonary failure | 1/5 (20%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Pleural effusion | 1/5 (20%) | 1 |
| Pulmonary embolus | 1/5 (20%) | |
Other (Not Including Serious) Adverse Events |
||
| CytoSorb 300 mL Device Treatment Population | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/5 (0%) | |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | CytoSorbents |
|---|---|
| Organization | CytoSorbents |
| Phone | 732-329-8885 |
| info@cytosorbents.com |
Responsible Party:
CytoSorbents, Inc
ClinicalTrials.gov Identifier:
NCT04131959
Other Study ID Numbers:
- 2018-002
- IRAS project ID 264064
First Posted:
Oct 18, 2019
Last Update Posted:
Mar 9, 2022
Last Verified:
Feb 1, 2022