Optimizing blood flow and anticoagulation for obese patients in heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and effectiveness of using lean body mass to determine pump flow rates and Heparin dosages in obese patients undergoing cardiac surgery with cardiopulmonary bypass. It aims to address the inadequacies of standard Heparin management based on total body weight for this population. By tailoring anticoagulation strategies, the study seeks to improve surgical outcomes and reduce complications associated with obesity during cardiac procedures.

Why it matters

Who can join: the full rules

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

Where it's running

• Hopital Laval
  Québec, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Pierre Voisine, MD — University Laval
• Study coordinator: Hugo Tremblay, Bachelor
• Email: hugo.tremblay@criucpq.ulaval.ca
• Phone: 418-656-8711

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.