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

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 Overview

• Status: Recruiting
• Conditions: Obesity; Cardiopulmonary Bypass
• Intervention / Treatment: Drug: Heparin; Procedure: cardiopulmonary bypass pump flow rate

• Study Type: Interventional
• Enrollment (Anticipated): 410
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Quebec City, Quebec, Canada, G1V 4G5
      • Recruiting
      • Hôpital Laval

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Heparin; Based on patient body weight (UI/kg); Procedure: cardiopulmonary bypass pump flow rate; Based on patient body weight (L/min/m2)
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.	Drug: Heparin; Based on patient body weight (UI/kg); Procedure: cardiopulmonary bypass pump flow rate; Based on patient body weight (L/min/m2)
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.	Drug: Heparin; Based on patient body weight (UI/kg); Procedure: cardiopulmonary bypass pump flow rate; Based on patient body weight (L/min/m2)
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.	Drug: Heparin; Based on patient body weight (UI/kg); Procedure: cardiopulmonary bypass pump flow rate; Based on patient body weight (L/min/m2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Allogeneic transfusions of red blood cells	Percentage of subjects avoiding any allogeneic transfusions of red blood cells	Seven days post-operatively or until discharge, whichever comes first

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Laval University
• Collaborators: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2015
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2027

Study Registration Dates

• First Submitted: September 28, 2017
• First Submitted That Met QC Criteria: October 3, 2017
• First Posted (Actual): October 5, 2017

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Obesity; Bleeding; Cardiac surgery; Heparin; Allogeneic blood product transfusions
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin
• Other Study ID Numbers: Obesity-CPB-21117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No