Ticagrelor CytoSorb Hemoadsorption

N/ATerminatedNCT04131959

CytoSorbents, Inc5 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Emergent Cardiothoracic Surgery Bleeding Drug Removal

Interventions

CytoSorb 300 mL deviceDEVICE

Intra-operative CytoSorb hemoadsorption of ticagrelor during cardiopulmonary bypass

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (8)

Queen Elizabeth Hospital

Birmingham, England, United Kingdom

Blackpool Victoria Hospital

Blackpool, England, United Kingdom

Harefield Hospital

Harefield, England, United Kingdom

Manchester Royal Infirmary

Manchester, England, United Kingdom

Outcomes

Primary Outcomes

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).

Time frame: Immediately before and after cardiopulmonary bypass

Primary Pharmacokinetic Endpoint

Percent change in ticagrelor blood concentration immediately before and after cardiopulmonary bypass.

Time frame: Immediately before and after cardiopulmonary bypass

Data from ClinicalTrials.gov

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