Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT03302195

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionCardiopulmonary Bypass, Obesity

Full registry 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

Treatments and study arms

Heparin

Drug

Based on patient body weight (UI/kg)

cardiopulmonary bypass pump flow rate

Procedure

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

Primary outcomes

Allogeneic transfusions of red blood cellsSeven days post-operatively or until discharge, whichever comes first

Percentage of subjects avoiding any allogeneic transfusions of red blood cells

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Hopital Laval🇨🇦 Québec, Quebec, Canada
Hugo Tremblay, BachelorContact