Active Clearance Technology (ACT) Registry

October 28, 2020 updated by: John M. Stulak

Prevention of Retained-Blood Outcomes With Active Clearance Technology- The 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Retrospective cohort
Prospective PleuralFlow cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Discharge from operating room for index-surgery through hospital discharge - approximate 30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

John M. Stulak

Investigators

  • Principal Investigator: John Stulak, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2016

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

February 11, 2016

First Submitted That Met QC Criteria

February 11, 2016

First Posted (Estimate)

February 15, 2016

Study Record Updates

Last Update Posted (Actual)

October 29, 2020

Last Update Submitted That Met QC Criteria

October 28, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 15-006388

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Retained Blood Syndrome

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe