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Active Clearance Technology (ACT) Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02682849
Recruitment Status : Active, not recruiting
First Posted : February 15, 2016
Last Update Posted : June 19, 2020
Information provided by (Responsible Party):
John M. Stulak, Mayo Clinic

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.

Condition or disease
Retained Blood Syndrome

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Study Type : Observational [Patient Registry]
Actual Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration: 30 Days
Official Title: Prevention of Retained-Blood Outcomes With Active Clearance Technology- The ACT Registry
Actual Study Start Date : May 10, 2016
Actual Primary Completion Date : May 2018
Estimated Study Completion Date : September 2020

Retrospective cohort
Prospective PleuralFlow cohort

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The control arm consists of a cohort of matched cardiac surgery patients with data entered over the preceding 12 to 24-month period. The site will consecutively enroll a cohort of cardiac surgery patients in the treatment arm.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02682849

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
John M. Stulak
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Principal Investigator: John Stulak, M.D. Mayo Clinic
Additional Information:
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Responsible Party: John M. Stulak, Principal Investigator, Mayo Clinic Identifier: NCT02682849    
Other Study ID Numbers: 15-006388
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: June 19, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No