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CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery

NCT03384875 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2024-12-04

Study results available
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Summary

Prospective, multi-center, randomized, blinded, pivotal clinical study. Subjects will be randomized in a 1:1 ratio to either standard of care (SOC) alone or standard of care plus treatment with the CytoSorb® device.

Conditions

  • Elective Cardiac Surgery

Interventions

DEVICE

CytoSorb

To evaluate the safety and performance of the CytoSorb® device to decrease the incidence or severity of acute kidney injury (AKI)

Sponsors & Collaborators

  • CytoSorbents, Inc

    lead INDUSTRY

Principal Investigators

  • Thomas Gleason, MD · not applicable- Unaffiliated with CytoSorbents

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-19
Primary Completion
2022-01-18
Completion
2022-01-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03384875 on ClinicalTrials.gov