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Trial record 1 of 2 for:    cytosorb ticagrelor
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Ticagrelor CytoSorb Hemoadsorption (TISORB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04131959
Recruitment Status : Terminated (Stalled study execution from the impact of the COVID-19 pandemic on the UK NHS)
First Posted : October 18, 2019
Results First Posted : March 9, 2022
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
CytoSorbents, Inc

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
Emergent Cardiothoracic Surgery Bleeding Drug Removal Device: CytoSorb 300 mL device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, 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 : October 29, 2019
Actual Primary Completion Date : May 4, 2021
Actual Study Completion Date : May 4, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ticagrelor

Arm Intervention/treatment
Experimental: Pharmacodynamic population
Single arm
Device: CytoSorb 300 mL device
Intra-operative CytoSorb hemoadsorption of ticagrelor during cardiopulmonary bypass




Primary Outcome Measures :
  1. Primary Pharmacodynamic Endpoint [ Time Frame: 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).

  2. Primary Pharmacokinetic Endpoint [ Time Frame: Immediately before and after cardiopulmonary bypass ]
    Percent change in ticagrelor blood concentration immediately before and after cardiopulmonary bypass.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04131959


Locations
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United Kingdom
Queen Elizabeth Hospital
Birmingham, England, United Kingdom, B15 2TH
Blackpool Victoria Hospital
Blackpool, England, United Kingdom, FY3 8NR
Harefield Hospital
Harefield, England, United Kingdom, UB9 6JH
Manchester Royal Infirmary
Manchester, England, United Kingdom, M13 9WL
Northern General Hospital
Sheffield, England, United Kingdom, S5 7AU
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Royal Infirmary of Edinburgh
Edinburgh, Scotland, United Kingdom, EH16 4SA
Golden Jubilee National Hospital
Glasgow, Scotland, United Kingdom, G81 4DY
Sponsors and Collaborators
CytoSorbents, Inc
Investigators
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Principal Investigator: Tom Clutton-Brock, MB, ChB NIHR Trauma Management, MedTech Cooperative
  Study Documents (Full-Text)

Documents provided by CytoSorbents, Inc:
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Responsible Party: CytoSorbents, Inc
ClinicalTrials.gov Identifier: NCT04131959    
Other Study ID Numbers: 2018-002
IRAS project ID 264064 ( Other Identifier: UK Integrated Research Approval System (IRAS) )
First Posted: October 18, 2019    Key Record Dates
Results First Posted: March 9, 2022
Last Update Posted: March 9, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes