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Active Clearance Technology (ACT) Registry

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ClinicalTrials.gov Identifier: NCT02682849
Recruitment Status : Active, not recruiting
First Posted : February 15, 2016
Last Update Posted : January 8, 2019
Sponsor:
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 : June 2019

Group/Cohort
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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02682849


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
John M. Stulak
Investigators
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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
ClinicalTrials.gov Identifier: NCT02682849     History of Changes
Other Study ID Numbers: 15-006388
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No