Comparing 4 approaches for cardiopulmonary bypass
Official title: Optimal Cardiopulmonary Bypass and Anticoagulation Management Strategies in Obese Patients Undergoing Cardiac Surgery
- 4 groups
- One site, in Québec
- Recruiting
Interventions
- Medication
Heparin
Based on patient body weight (UI/kg)
- Medical procedure
cardiopulmonary bypass pump flow rate
Based on patient body weight (L/min/m2)
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Hopital Laval
Québec, Quebec
Eligibility Criteria
See who this study is looking for33 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age ≥ 18 years
- +Obese patients (BMI ≥ 30kg/m2)
- +Planned cardiac surgery
Exclusion
- −Known or suspected allergy to the used antifibrinolytic agent
- −Permanent pacemaker
- −Known intolerance to protamine
- −Refusal to receive blood products
- −Planned off pump coronary artery bypass
- −Planned peri-operative use of desmopressin
- −Known Heparin-induced thrombocytopenia
- −Known deficiency in protein C, protein S, antithrombin or homozygous factor V Leiden
- −Known congenital bleeding disorders
- −Current endocarditis
- −Planned hypothermic circulatory arrest (\<28C)
- −Planned CPB priming with red blood cells
- −Any known autoimmune disease
- −Any history of stroke or non-coronary thrombotic disorders including deep venous thrombosis and pulmonary embolism
- −Significant (≥50%) carotid artery stenosis
- −Confirmed ST elevation myocardial infarction (STEMI) within 7 days
- −Pre-operative platelet count \<100,000/microliter
- −Anaemia (Hematocrit \<32% for females, \<35%for males)
- −Liver dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) increased ≥ 2-fold above the upper limit of local laboratory normal ranges)
- −Renal failure (creatinine ≥ 175 micromol/L or dialysis)
- −Current thromboembolic disease other than myocardial infarct
- −Patients who have pre-donated autologous blood
- −Patient presenting with a resistance to Heparin
- −Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
- −Two or more cardiac surgery procedures
- −Emergency cardiac surgery procedures (medically required within 24hours of presenting with acute symptoms)
- −Patient dosed with low molecular weight Heparin less than 24h before surgery
- −Dosed with clopidogrel or ticagrelor within the last 5 days prior to surgery, or prasugrel within 7 days
- −Dosed with GPIIb/IIIa receptor blockers (Abciximab, Tirofiban, Eptifibatide) ≤ 24 hours prior to surgery
- −International ratio (INR) \>1.5 on the day of surgery in patients treated with vitamin K antagonist
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 4 groups in this study.
Group A, the comparison group, receives one or more of: Heparin and cardiopulmonary bypass pump flow rate.
Registry label: A: Control group
Groups B, C and D receive one or more of: Heparin and cardiopulmonary bypass pump flow rate.
Registry label: B: Intervention group A · C: Intervention group B · D: Intervention group C
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 410 people.
The study is currently expected to finish around December 2027.
The main measurement is taken over: Seven days post-operatively or until discharge, whichever comes first.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Allogeneic transfusions of red blood cells — measured over Seven days post-operatively or until discharge, whichever comes first.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT03302195 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About HeparinDrug
Based on patient body weight (UI/kg)
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About cardiopulmonary bypass pump flow rateProcedure
Based on patient body weight (L/min/m2)
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Seven days post-operatively or until discharge, whichever comes first.
The study as a whole is currently expected to finish around 2027-12-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 410 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Québec, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Standard Heparin management, based on total body weight, is not well established for obese patients undergoing cardiac surgery with cardiopulmonary bypass (CPB). The purpose of this study is to assess the safety and efficacy of using lean body mass (LBM) to determine pump flow rate and/or Heparin dosage in obese patients undergoing CPB.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.