Ticagrelor CytoSorb Hemoadsorption

NCT ID: NCT04131959

Last Updated: 2022-03-09

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-29

Study Completion Date

2021-05-04

Brief Summary

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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.

Detailed Description

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Conditions

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Emergent Cardiothoracic Surgery Bleeding Drug Removal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, open, multi-center, single arm study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pharmacodynamic population

Single arm

Group Type EXPERIMENTAL

CytoSorb 300 mL device

Intervention Type DEVICE

Intra-operative CytoSorb hemoadsorption of ticagrelor during cardiopulmonary bypass

Interventions

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CytoSorb 300 mL device

Intra-operative CytoSorb hemoadsorption of ticagrelor during cardiopulmonary bypass

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CytoSorbents, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tom Clutton-Brock, MB, ChB

Role: PRINCIPAL_INVESTIGATOR

NIHR Trauma Management, MedTech Cooperative

Locations

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Queen Elizabeth Hospital

Birmingham, England, United Kingdom

Site Status

Blackpool Victoria Hospital

Blackpool, England, United Kingdom

Site Status

Harefield Hospital

Harefield, England, United Kingdom

Site Status

Manchester Royal Infirmary

Manchester, England, United Kingdom

Site Status

Northern General Hospital

Sheffield, England, United Kingdom

Site Status

Aberdeen Royal Infirmary

Aberdeen, Scotland, United Kingdom

Site Status

Royal Infirmary of Edinburgh

Edinburgh, Scotland, United Kingdom

Site Status

Golden Jubilee National Hospital

Glasgow, Scotland, United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRAS project ID 264064

Identifier Type: OTHER

Identifier Source: secondary_id

2018-002

Identifier Type: -

Identifier Source: org_study_id

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