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Completed

NCT Number: NCT02682849

Active Clearance Technology (ACT) Registry

The purpose of this study is to evaluate the effectiveness of the PleuraFlow® Active Clearance Technology™ (ACT) System in the management of blood evacuation after cardiac surgery.

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Key information

Conditions

Retained Blood Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or Female subjects 18 years of age or older who received a PleuraFlow System following heart surgery.
  • Patient undergoing cardiac surgery via sternotomy

Exclusion criteria

  • Robotic surgery
  • Any access via thoracotomy
  • Any condition deemed inappropriate for inclusion by the investigators.
  • Intolerance to implantable silicone materials.

Treatment and study plan

Primary outcomes

  1. Number of interventions to Treat Retained Blood Syndrome

    Time frame: Discharge from operating room for index-surgery through hospital discharge - approximate 30 days

    Retained Blood Syndrome (RBS) is defined by a composite endpoint of specific reoperation for bleeding, pericardial effusion, and hemothorax.

Secondary outcomes

  1. Number of episodes of new on set of post operative atrial fibrillations (POAS)

    Time frame: 30 day

  2. Number of readmissions for any diagnosis of RBS or POAS re-occurrences

    Time frame: 30 day

Sponsors and collaborators

Lead sponsor

John M. Stulak

Other

Registry information

Official study title

Prevention of Retained-Blood Outcomes With Active Clearance Technology- The ACT Registry

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Feb 15, 2016
Registry last updated
Oct 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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