CompletedNot Applicable

Heparin Dose and Post Operative Bleeding in Cardiopulmonary Bypass Patients

Canada66 participantsStarted 2012-05

Plain-language summary

Blood is anticoagulated using a drug named heparin during open-heart surgery to allow it to safely pass through the heart-lung machine which pumps the blood throughout the body during the surgery. Each patient is given the heparin they need for their surgery. This means some patients receive more or less heparin than other patients. In this study, the investigators will be evaluating the current anticoagulation protocol for open heart surgery in use at the Royal University Hospital. The goal of this project is to compare patients who require and receive more heparin for proper anticoagulation to those patients who require and receive less heparin. Open-heart surgery will proceed according to the standard hospital protocol. All research participants will be treated according to standard post-open heart surgery protocol in the ICU. This will include measurement of blood loss by keeping track of chest tube outputs and administration of blood transfusions. This study focuses on Saskatoon Health Region patients having open heart surgery in terms of the protocol for anticoagulation and blood transfusions.

Who can participate

Age range

40 Years – 85 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: * Patients scheduled for elective or urgent CABG of two to six vessels. Exclusion Criteria: * Preoperative: * Hemoglobin of less than 110grams/Litre * Under 18 years of age * Mass less than 75 kilograms * Presence of an intra-aortic balloon pump * Emergency surgery, requiring operative intervention within 24 hours of consultation to the cardiac surgery team * Need for cardiac surgical intervention in addition to planned CABG (with the exception of patent foramen ovale closure) * Ejection fraction of less than 50%, as determined by echocardiogram or angiography * Pulmonary hypertension with pulmonary artery pressures greater than 60mmHg * Presence of infectious endocarditis * Hepatic failure with impaired liver function, including INR greater than 1.5 Known diagnosed bleeding disorder * History of heparin induced thrombocytopenia and thrombosis * Renal failure with pre-operative creatinine greater than 200ml/min or oliguria with urine output less than 10millilitres/hour * Allergy to tranexamic acid * Pregnancy Intraoperative: * Discovery of infectious endocarditis * Need for cardiac surgical intervention in addition to planned coronary CABG

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

Chest Tube Losses

Timeframe: Chest tube losses are recorded from departure from operating room to chest tube removal in the ICU (normally less than 24 hrs)

Trial details

NCT IDNCT01574105

SponsorUniversity of Saskatchewan

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2013-01

Results submitted2013-06-18

View on ClinicalTrials.gov More Coronary Artery Disease trials