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

Not Applicable

Recruiting

• Conditions: Obesity; Cardiopulmonary Bypass
• Interventions: Drug: Heparin; Procedure: cardiopulmonary bypass pump flow rate

• Registration Number: NCT03302195
• Lead Sponsor: Laval University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-21
• Study First Submitted: 2017-09-28
• Study First Submitted QC: 2017-10-03
• Study First Posted: 2017-10-05
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-09
• Last Update Posted: 2023-03-10
• Primary Completion: 2024-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 410

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	cardiopulmonary bypass pump flow rate	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.
Intervention group A	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.
Intervention group C	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.
Intervention group B	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.
Control group	Heparin	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.
Intervention group A	Heparin	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.
Intervention group B	Heparin	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.
Intervention group C	Heparin	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
Bleeding	Peroperative, 4 and 24 hours post-operative	Per- and post-operative bleeding
Post-operative complications	Post-operatively from day 0 up to first hospital discharge	Monitoring the safety of strategies by monitoring post-operative complications

Trial Locations

Locations (1)

Hopital Laval; 🇨🇦 Quebec City, Quebec, Canada