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Ticagrelor CytoSorb Hemoadsorption (TISORB)

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ClinicalTrials.gov Identifier: NCT04131959
Recruitment Status : Recruiting
First Posted : October 18, 2019
Last Update Posted : November 26, 2019
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)
Estimated Enrollment : 30 participants
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 Cardiothoracic Surgery
Actual Study Start Date : October 29, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : August 2020

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 immediately before and after cardiopulmonary bypass

  2. Primary pharmacokinetic endpoint [ Time Frame: Immediately before and after cardiopulmonary bypass ]
    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


Contacts
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Contact: Ola Ogunsakin, MD +1 504-715-5677 oogunsakin@cytosorbents.com

Locations
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United Kingdom
Harefield Hospital Recruiting
Harefield, England, United Kingdom, UB9 6JH
Contact: Ola Ogansakin, MD    +1 504-715-5677    oogunsakin@cytosorbents.com   
Aberdeen Royal Infirmary Recruiting
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Contact: Ola Ogunsakin, MD    +1 504-715-5677    oogunsakin@cytosorbents.com   
Golden Jubilee National Hospital Recruiting
Glasgow, Scotland, United Kingdom, G81 4DY
Contact: Ola Ogansakin, MD    +1 504-715-5677    oogunsakin@cytosorbents.com   
Sponsors and Collaborators
CytoSorbents, Inc
Investigators
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Principal Investigator: Tom Clutton-Brock, MB, ChB NIHR Trauma Management, MedTech Cooperative

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Responsible Party: CytoSorbents, Inc
ClinicalTrials.gov Identifier: NCT04131959     History of Changes
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
Last Update Posted: November 26, 2019
Last Verified: October 2019

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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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Ticagrelor
Hemorrhage
Pathologic Processes
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs