Cardiopulmonary Bypass, Obesity
Conditions
Keywords
Heparin, Allogeneic blood product transfusions, Bleeding, Cardiac surgery, Obesity
Brief 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 patients undergoing CPB.
Interventions
DRUGHeparin
Based on patient body weight (UI/kg)
PROCEDUREcardiopulmonary bypass pump flow rate
Based on patient body weight (L/min/m2)
Sponsors
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Laval University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participant is blinded to group assignment
Intervention model description
Randomized control prospective trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Obese patients (BMI ≥ 30kg/m2) * Planned cardiac surgery * Age ≥ 18 years
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Allogeneic transfusions of red blood cells | Seven days post-operatively or until discharge, whichever comes first | Percentage of subjects avoiding any allogeneic transfusions of red blood cells |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Allogeneic transfusions of blood products | Seven days post-operatively or until discharge, whichever comes first | Percentage of subjects avoiding any allogeneic transfusions |
| Units of blood product transfusions | Seven days post-operatively or until discharge, whichever comes first | Number of units of transfused blood products |
| Massive red blood cell transfusions | Seven days post-operatively or until discharge, whichever comes first | Percentage of subjects avoiding massive red blood cell transfusion (more than 5 units) |
| Post-operative complications | Post-operatively from day 0 up to first hospital discharge | Monitoring the safety of strategies by monitoring post-operative complications |
| Bleeding | Peroperative, 4 and 24 hours post-operative | Per- and post-operative bleeding |
Countries
Canada
Contacts
Primary ContactHugo Tremblay, Bachelor
Outcome results
None listed