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

NCT ID: NCT03302195

Last Updated: 2023-03-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 410 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-21
• Study Completion Date: 2027-12-31

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.

Conditions

Cardiopulmonary Bypass; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Heparin

Intervention Type: DRUG

Based on patient body weight (UI/kg)

cardiopulmonary bypass pump flow rate

Intervention Type: PROCEDURE

Based on patient body weight (L/min/m2)

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.

Group Type: EXPERIMENTAL

Heparin

Intervention Type: DRUG

Based on patient body weight (UI/kg)

cardiopulmonary bypass pump flow rate

Intervention Type: PROCEDURE

Based on patient body weight (L/min/m2)

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.

Group Type: EXPERIMENTAL

Heparin

Intervention Type: DRUG

Based on patient body weight (UI/kg)

cardiopulmonary bypass pump flow rate

Intervention Type: PROCEDURE

Based on patient body weight (L/min/m2)

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.

Group Type: EXPERIMENTAL

Heparin

Intervention Type: DRUG

Based on patient body weight (UI/kg)

cardiopulmonary bypass pump flow rate

Intervention Type: PROCEDURE

Based on patient body weight (L/min/m2)

Interventions

Heparin

Based on patient body weight (UI/kg)

Intervention Type: DRUG

cardiopulmonary bypass pump flow rate

Based on patient body weight (L/min/m2)

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

OTHER

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Pierre Voisine

Cardiac surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pierre Voisine, MD

Role: PRINCIPAL_INVESTIGATOR

University Laval

Locations

Hopital Laval

Québec, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Hugo Tremblay, Bachelor

Role: CONTACT

hugo.tremblay@criucpq.ulaval.ca

418-656-8711 ext. 3797

Facility Contacts

Hugo Tremblay, Bachelor

Role: primary

hugo.tremblay@criucpq.ulaval.ca

418-656-8711 ext. 3797

Other Identifiers

Obesity-CPB-21117

Identifier Type: -

Identifier Source: org_study_id