RecruitingNot ApplicableNCT03302195

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

Sponsor

Laval University

Enrollment

410 participants

Start Date

Aug 21, 2015

Study Type

INTERVENTIONAL

Conditions

Obesity Cardiopulmonary Bypass

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

Obese patients (BMI ≥ 30kg/m2)
Planned cardiac surgery
Age ≥ 18 years

Exclusion Criteria30

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