Optimal Cardiopulmonary Bypass and Anticoagulation Management Strategies in Obese Patients Undergoing Cardiac Surgery

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 31, 2024

Interventions

  • Drug: Heparin
    • Based on patient body weight (UI/kg)
  • Procedure: cardiopulmonary bypass pump flow rate
    • Based on patient body weight (L/min/m2)

Arms, Groups and Cohorts

  • Active Comparator: Control group
    • 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.
  • Experimental: Intervention group A
    • 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.
  • Experimental: Intervention group B
    • 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.
  • Experimental: Intervention group C
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • Allogeneic transfusions of blood products
    • Time Frame: Seven days post-operatively or until discharge, whichever comes first
    • Percentage of subjects avoiding any allogeneic transfusions
  • Units of blood product transfusions
    • Time Frame: Seven days post-operatively or until discharge, whichever comes first
    • Number of units of transfused blood products
  • Massive red blood cell transfusions
    • Time Frame: 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
    • Time Frame: Post-operatively from day 0 up to first hospital discharge
    • Monitoring the safety of strategies by monitoring post-operative complications
  • Bleeding
    • Time Frame: Peroperative, 4 and 24 hours post-operative
    • Per- and post-operative bleeding

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Laval University
  • Collaborator
    • Centre de Recherche de l’Institut Universitaire de Cardiologie et de Pneumologie de Quebec
  • Provider of Information About this Clinical Study
    • Principal Investigator: Pierre Voisine, Cardiac surgeon – Laval University
  • Overall Official(s)
    • Pierre Voisine, MD, Principal Investigator, University Laval
  • Overall Contact(s)
    • Hugo Tremblay, Bachelor, 418-656-8711, hugo.tremblay@criucpq.ulaval.ca

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