Ticagrelor CytoSorb Hemoadsorption (TISORB)

CytoSorbents

Status: Terminated

Conditions: Emergent Cardiothoracic Surgery; Drug Removal; Bleeding

Treatments: Device: CytoSorb 300 mL device

Study type: Interventional

Funder types: Industry

Identifiers

NCT04131959

2018-002

IRAS project ID 264064 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Pharmacodynamic population

Experimental group

Description:

Single arm

Treatment:

Device: CytoSorb 300 mL device