An interventional study of Heparin and cardiopulmonary bypass pump flow rate in Cardiopulmonary Bypass and Obesity, sponsored by Laval University. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-10.
Sponsored by Laval University · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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.
Drug: Heparin · Procedure: cardiopulmonary bypass pump flow rate
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.
Drug: Heparin · Procedure: cardiopulmonary bypass pump flow rate
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.
Drug: Heparin · Procedure: cardiopulmonary bypass pump flow rate
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.
Drug: Heparin · Procedure: cardiopulmonary bypass pump flow rate
Based on patient body weight (UI/kg)
Based on patient body weight (L/min/m2)
Allogeneic transfusions of red blood cells
Percentage of subjects avoiding any allogeneic transfusions of red blood cells
Time frame: Seven days post-operatively or until discharge, whichever comes first
Allogeneic transfusions of blood products
Percentage of subjects avoiding any allogeneic transfusions
Time frame: Seven days post-operatively or until discharge, whichever comes first
Units of blood product transfusions
Number of units of transfused blood products
Time frame: 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)
Time frame: Seven days post-operatively or until discharge, whichever comes first
Post-operative complications
Monitoring the safety of strategies by monitoring post-operative complications
Time frame: Post-operatively from day 0 up to first hospital discharge
Bleeding
Per- and post-operative bleeding
Time frame: Peroperative, 4 and 24 hours post-operative
Plan to share: No
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Laval University