Active Clearance Technology (ACT) Registry

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02682849

Enrollment

500

Registered

2016-02-15

Start date

2016-05-10

Completion date

2020-03-31

Last updated

2020-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retained Blood Syndrome

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Male or Female subjects 18 years of age or older who received a PleuraFlow System following heart surgery. 2. Patient undergoing cardiac surgery via sternotomy

Exclusion criteria

1. Robotic surgery 2. Any access via thoracotomy 3. Any condition deemed inappropriate for inclusion by the investigators. 4. Intolerance to implantable silicone materials.

Design outcomes

Primary

Measure	Time frame	Description
Number of interventions to Treat Retained Blood Syndrome	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

Measure	Time frame
Number of episodes of new on set of post operative atrial fibrillations (POAS)	30 day
Number of readmissions for any diagnosis of RBS or POAS re-occurrences	30 day

Countries

United States

Outcome results