Clinical trial NCT03302195: Optimal Cardiopulmonary Bypass and Anticoagulation Management Strategies in Obese Patients Undergoing Cardiac Surgery
Official title: Optimal Cardiopulmonary Bypass and Anticoagulation Management Strategies in Obese Patients Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiopulmonary Bypass
Obesity
Keywords: Heparin
Allogeneic blood product transfusions
Bleeding
Cardiac surgery
Obesity
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
First posted: 2017-10-05
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control prospective trial
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Allogeneic transfusions of red blood cells
timeFrame: Seven days post-operatively or until discharge, whichever comes first
Secondary outcomes:
measure: Allogeneic transfusions of blood products
timeFrame: Seven days post-operatively or until discharge, whichever comes first
measure: Units of blood product transfusions
timeFrame: Seven days post-operatively or until discharge, whichever comes first
measure: Massive red blood cell transfusions
timeFrame: Seven days post-operatively or until discharge, whichever comes first
measure: Post-operative complications
timeFrame: Post-operatively from day 0 up to first hospital discharge
measure: Bleeding
timeFrame: Peroperative, 4 and 24 hours post-operative
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: Hopital Laval
state: Quebec
Study officials:
affiliation: University Laval
name: Pierre Voisine, MD
role: PRINCIPAL_INVESTIGATOR
References: