TerminatedNot Applicable

The CardioPAT Project: A Randomized Trial

Stopped: Due to other trials in the department

Denmark68 participantsStarted 2013-12

Plain-language summary

The purpose of this study is to determine whether intra- and postoperative use of the cardioPAT® cell saver decreases the need for allogenic red blood cell transfusion in patients, who undergo open heart surgery (with cardiopulmonary bypass) and preoperatively have an increased risk for bleeding.

Who can participate

Age range

18 Years – 100 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: * All the women * Men with a hemoglobin \< 8mmol/L * Men \> 75 years of age with combined procedures, that is combined CABG and valve surgery, regardless of preoperative hemoglobin level * Sub-acute patients can be included Exclusion Criteria: * Re-operation within the first 24 hours * Known clotting disorders (coagulopathy) or hematological diseases * Sepsis, f ex due to Endocarditis * Patients who are already enrolled in other studies, where data from the studies are at risk of interfering with each other * Jehovah's witnesses * Acute surgery (\< 24 hours)

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

The rate of allogenic transfusion with red blood cells (SAG-M)

Timeframe: The entire stay at the Department of Cardiothoracic Surgery, Rigshospitalet (approximately one week after surgery)

Trial details

NCT IDNCT02058134

SponsorRigshospitalet, Denmark

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-12

View on ClinicalTrials.gov More Coronary Artery Disease trials

Who can participate

Age range

18 Years – 100 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.