Ticagrelor CytoSorb Hemoadsorption (TISORB)

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

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.

Study Overview

• Status: Terminated
• Conditions: Bleeding; Emergent Cardiothoracic Surgery; Drug Removal
• Intervention / Treatment: Device: CytoSorb 300 mL device

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • England
    • Birmingham, England, United Kingdom, B15 2TH
      • Queen Elizabeth Hospital
    • Blackpool, England, United Kingdom, FY3 8NR
      • Blackpool Victoria Hospital
    • Harefield, England, United Kingdom, UB9 6JH
      • Harefield Hospital
    • Manchester, England, United Kingdom, M13 9WL
      • Manchester Royal Infirmary
    • Sheffield, England, United Kingdom, S5 7AU
      • Northern General Hospital
  • Scotland
    • Aberdeen, Scotland, United Kingdom, AB25 2ZN
      • Aberdeen Royal Infirmary
    • Edinburgh, Scotland, United Kingdom, EH16 4SA
      • Royal Infirmary of Edinburgh
    • Glasgow, Scotland, United Kingdom, G81 4DY
      • Golden Jubilee National Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pharmacodynamic population; Single arm	Device: CytoSorb 300 mL device; Intra-operative CytoSorb hemoadsorption of ticagrelor during cardiopulmonary bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: CytoSorbents, Inc
• Investigators: Principal Investigator: Tom Clutton-Brock, MB, ChB, NIHR Trauma Management, MedTech Cooperative

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 29, 2019
• Primary Completion (ACTUAL): May 4, 2021
• Study Completion (ACTUAL): May 4, 2021

Study Registration Dates

• First Submitted: October 15, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (ACTUAL): October 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 9, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2018-002; IRAS project ID 264064 (OTHER: UK Integrated Research Approval System (IRAS))

Drug and device information, study documents

• 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