NCT04131959

Ticagrelor CytoSorb Hemoadsorption

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: CytoSorbents, Inc · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Emergent Cardiothoracic Surgery
• Bleeding
• Drug Removal

Interventions

Type	Name	Description
DEVICE	CytoSorb 300 mL device	Intra-operative CytoSorb hemoadsorption of ticagrelor during cardiopulmonary bypass

Timeline

• Start date: 2019-10-29
• Primary completion: 2021-05-04
• Completion: 2021-05-04
• First posted: 2019-10-18
• Last updated: 2022-03-09
• Results posted: 2022-03-09

Locations

8 sites across 1 country: United Kingdom

Regulatory

• FDA-regulated device study