Cardiopulmonary BypassNCT03302195
Optimal Cardiopulmonary Bypass and Anticoagulation Management Strategies in Obese Patients Undergoing Cardiac Surgery
A study testing Heparin and cardiopulmonary bypass pump flow rate in people with Cardiopulmonary Bypass and Obesity, run by Laval University at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiopulmonary Bypass, Obesity
- What is being tested?
- Heparin and cardiopulmonary bypass pump flow rate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 1 siteCanada
- Study dates
- 21 Aug 2015to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obese patients (BMI ≥ 30kg/m2)
- Planned cardiac surgery
- Age ≥ 18 years
Who cannot join
- Permanent pacemaker
- Known intolerance to protamine
- Known or suspected allergy to the used antifibrinolytic agent
- Refusal to receive blood products
- Planned off pump coronary artery bypass
- Planned peri-operative use of desmopressin
Show all 30Show fewer
- 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)
- Two or more cardiac surgery procedures
- Emergency cardiac surgery procedures (medically required within 24hours of presenting with acute symptoms)
- 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
- Patient dosed with low molecular weight Heparin less than 24h before surgery
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
- Confirmed ST elevation myocardial infarction (STEMI) within 7 days
- Pre-operative platelet count <100,000/microliter
- Anaemia (Hematocrit <32% for females, <35%for males)
- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Hopital Laval
Québec, Quebec, G1V 4G5
Hugo Tremblay, Bachelor, 418-656-8711 ext. 3797, hugo.tremblay@criucpq.ulaval.ca
About this study
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.
- Conditions
- Cardiopulmonary Bypass, Obesity
- Being tested
- Heparin, cardiopulmonary bypass pump flow rate
- Keywords
- Heparin, Allogeneic blood product transfusions, Bleeding, Cardiac surgery, Obesity
- Medical subject headings
- Obesity, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeparinDrug
Based on patient body weight (UI/kg)
cardiopulmonary bypass pump flow rateProcedure or surgery
Based on patient body weight (L/min/m2)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Heparin dose and cardiopulmonary bypass pump flow rate are calculated using total body weight.
An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated. Receives: Drug: Heparin; Procedure: cardiopulmonary bypass pump flow rate |
| Intervention group A | Experimental | Heparin dose is adjusted for lean body weight and cardiopulmonary bypass pump flow rate is calculated using total body weight.
An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated. Receives: Drug: Heparin; Procedure: cardiopulmonary bypass pump flow rate |
| Intervention group B | Experimental | Heparin dose is calculated using total body weight and cardiopulmonary bypass pump flow rate is adjusted for lean body weight.
An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated. Receives: Drug: Heparin; Procedure: cardiopulmonary bypass pump flow rate |
| Intervention group C | Experimental | Heparin dose and cardiopulmonary bypass pump flow rate are adjusted for lean body weight.
An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated. Receives: Drug: Heparin; Procedure: cardiopulmonary bypass pump flow rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allogeneic transfusions of red blood cells
Percentage of subjects avoiding any allogeneic transfusions of red blood cells
Measured: Seven days post-operatively or until discharge, whichever comes first
Secondary outcomes (5)
Allogeneic transfusions of blood products
Percentage of subjects avoiding any allogeneic transfusions
Measured: Seven days post-operatively or until discharge, whichever comes first
Units of blood product transfusions
Number of units of transfused blood products
Measured: Seven days post-operatively or until discharge, whichever comes first
Massive red blood cell transfusions
Percentage of subjects avoiding massive red blood cell transfusion (more than 5 units)
Measured: Seven days post-operatively or until discharge, whichever comes first
Post-operative complications
Monitoring the safety of strategies by monitoring post-operative complications
Measured: Post-operatively from day 0 up to first hospital discharge
Bleeding
Per- and post-operative bleeding
Measured: Peroperative, 4 and 24 hours post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start21 Aug 2015
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary BypassStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control prospective trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- Responsible party
- Principal investigator, Pierre Voisine, Laval University
- Investigators
- Pierre Voisine, MD, Principal investigator, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302195
- Sponsor's protocol ID
- Obesity-CPB-21117
- Status last verified
- Mar 2023
- First submitted
- 28 Sep 2017
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Cardiopulmonary Bypass and Anticoagulation Management Strategies in Obese Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03302195
- Acronym / sponsor ID
- Obesity-CPB-21117
- Conditions
- Cardiopulmonary Bypass, Obesity
- Keywords
- Heparin, Allogeneic blood product transfusions, Bleeding, Cardiac surgery, Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- Study start
- 21 Aug 2015 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Randomized control prospective trial
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Heparin, Procedure: cardiopulmonary bypass pump flow rateHeparin dose and cardiopulmonary bypass pump flow rate are calculated using total body weight. An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated. |
| Intervention group A | Experimental | Drug: Heparin, Procedure: cardiopulmonary bypass pump flow rateHeparin dose is adjusted for lean body weight and cardiopulmonary bypass pump flow rate is calculated using total body weight. An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated. |
| Intervention group B | Experimental | Drug: Heparin, Procedure: cardiopulmonary bypass pump flow rateHeparin dose is calculated using total body weight and cardiopulmonary bypass pump flow rate is adjusted for lean body weight. An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated. |
| Intervention group C | Experimental | Drug: Heparin, Procedure: cardiopulmonary bypass pump flow rateHeparin dose and cardiopulmonary bypass pump flow rate are adjusted for lean body weight. An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Obese patients (BMI ≥ 30kg/m2)
- Planned cardiac surgery
- Age ≥ 18 years
Key exclusion criteria (30 listed)
- Permanent pacemaker
- Known intolerance to protamine
- Known or suspected allergy to the used antifibrinolytic agent
- Refusal to receive blood products
- Planned off pump coronary artery bypass
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeparinBased on patient body weight (UI/kg) | Drug | Control group, Intervention group A, Intervention group B, Intervention group C |
| cardiopulmonary bypass pump flow rateBased on patient body weight (L/min/m2) | Procedure or surgery | Control group, Intervention group A, Intervention group B, Intervention group C |
Primary outcome
Allogeneic transfusions of red blood cells
Time frame: Seven days post-operatively or until discharge, whichever comes first
Percentage of subjects avoiding any allogeneic transfusions of red blood cells
5 secondary outcomes
Allogeneic transfusions of blood products
Time frame: Seven days post-operatively or until discharge, whichever comes first
Units of blood product transfusions
Time frame: Seven days post-operatively or until discharge, whichever comes first
Massive red blood cell transfusions
Time frame: Seven days post-operatively or until discharge, whichever comes first
Post-operative complications
Time frame: Post-operatively from day 0 up to first hospital discharge
Bleeding
Time frame: Peroperative, 4 and 24 hours post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Cardiopulmonary Bypass
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Recruiting
Change in Platelet Lipid Metabolism and Procoagulant Phenotype Induced by Cardiopulmonary Bypass. Impact on Postoperative Inflammatory Response and Bleeding Complications During Cardiac Surgery.
Cardiac Surgery, Cardiopulmonary Bypass
Recruiting
Optimized Cardiopulmonary Bypass Flow Strategy Based on Ideal Body Weight in Obese Patients Undergoing Cardiac Surgery
Cardiopulmonary Bypass, Obese Patients
RecruitingObservational study
Hemodynamic Evaluation and Assessment of DIRECT myocaRdial and Sublingual Capillary Perfusion in Thoracic Surgery Patients on Cardiopulmonary Bypass
Microcirculatory Perfusion
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A Study to Understand How Cardiac Surgery-associated Acute Kidney Injury Develops in Participants Who Undergo Heart Surgery With the Use of Heart-lung Machine
Cardiac Surgery-associated Acute Kidney Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pierre Voisine, MD principal investigator
University Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heparin and cardiopulmonary bypass pump flow rate in people with Cardiopulmonary Bypass and Obesity, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hugo Tremblay, Bachelor (418-656-8711 ext. 3797, hugo.tremblay@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Allogeneic transfusions of red blood cells (time frame: Seven days post-operatively or until discharge, whichever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.