Active Clearance of Chest Tubes After Cardiac Surgery: A Prospective Randomized Controlled Study (NCT02808897) | Clinical Trial Compass
CompletedNot Applicable
Active Clearance of Chest Tubes After Cardiac Surgery: A Prospective Randomized Controlled Study
Canada520 participantsStarted 2015-11
Plain-language summary
The purpose of this study is to assess the effectiveness of the PleuraFlow® Active Tube Clearance (ATC) technology in reducing the rate of postoperative atrial fibrillation (POAF) among post cardiac surgery patients and to evaluate the impact of Active Tube Clearance (ATC) on other complications, such as retained blood syndrome (RBS), a composite endpoint including re-exploration for bleeding or tamponade, and interventions for hemothorax, pericardial or pleural effusion.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Admission for coronary artery bypass graft (CABG), valve replacement or valve repair surgery, or a combination of these surgeries;
. Surgical procedure(s) on the ascending aorta and/or aortic arch that do not require deep hypothermic arrest (deep hypothermic arrest is defined as \< 18° C);
. Must be in sinus rhythm (SR) for a minimum of 30 days prior to the index surgery and at the start of the index surgery. No patient with history of atrial fibrillation.
. Sign the institutional review board/institutional ethics committee approved informed consent form after the nature of the study has been explained and questions/concern have been addressed.
Exclusion criteria
. Admitted for surgical treatment of arrhythmia or Atrial fibrillation history;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Postoperative Atrial Fibrillation
Timeframe: From post index surgery through hospital discharge, an average of 30 days