Trial Outcomes & Findings for Ticagrelor CytoSorb Hemoadsorption (NCT NCT04131959)

NCT ID: NCT04131959

Last Updated: 2022-03-09

Results Overview

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).

Recruitment status

TERMINATED

Study phase

Target enrollment

5 participants

Primary outcome timeframe

Immediately before and after cardiopulmonary bypass

Results posted on

2022-03-09

Participant Flow

Participant milestones

Participant milestones
Measure	CytoSorb 300 mL Device Treatment Population Single arm
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ticagrelor CytoSorb Hemoadsorption

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CytoSorb 300 mL Device Treatment Population n=5 Participants Single arm
Age, Continuous	69 years STANDARD_DEVIATION 11.2 • n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	5 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United Kingdom	5 Participants n=99 Participants
Study patient with last dose of Ticagrelor within 48 hours of surgery	5 Participants n=99 Participants

PRIMARY outcome

Timeframe: Immediately before and after cardiopulmonary bypass

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).

Outcome measures

Outcome measures
Measure	CytoSorb 300 mL Device Treatment Population n=5 Participants Single arm
Primary Pharmacodynamic Endpoint	7 Aggregation Units (AU) Standard Deviation 8

PRIMARY outcome

Timeframe: Immediately before and after cardiopulmonary bypass

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

Outcome measures

Outcome measures
Measure	CytoSorb 300 mL Device Treatment Population n=5 Participants Single arm
Primary Pharmacokinetic Endpoint	63 Percent change Standard Deviation 12

Adverse Events

CytoSorb 300 mL Device Treatment Population

Serious events: 3 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	CytoSorb 300 mL Device Treatment Population n=5 participants at risk Single arm
Respiratory, thoracic and mediastinal disorders Pleural effusion	20.0% 1/5 • Number of events 1 • Up to 30 days after surgery
Cardiac disorders Cardiopulmonary failure	20.0% 1/5 • Up to 30 days after surgery
Respiratory, thoracic and mediastinal disorders Pulmonary embolus	20.0% 1/5 • Up to 30 days after surgery

Other adverse events

Adverse event data not reported

Additional Information

CytoSorbents

Phone: 732-329-8885

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place