Optimizing blood flow and anticoagulation for obese patients in heart surgery
Optimal Cardiopulmonary Bypass and Anticoagulation Management Strategies in Obese Patients Undergoing Cardiac Surgery
This study is testing if using a patient's lean body mass to guide blood flow and medication during heart surgery can help obese patients have better outcomes and fewer complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 410 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Laval University Academic / other |
| Drugs / interventions | Abciximab |
| Locations | 1 site (Québec, Quebec) |
| Trial ID | NCT03302195 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are obese patients with a BMI of 30 kg/m² or higher who are scheduled for cardiac surgery.
Not a fit: Patients with certain conditions such as known Heparin-induced thrombocytopenia or those requiring emergency cardiac surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more effective cardiac surgeries for obese patients, minimizing complications related to anticoagulation.
How similar studies have performed: While the specific approach of using lean body mass for Heparin dosing in obese patients is novel, similar studies have shown the importance of tailored anticoagulation strategies in improving surgical outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Québec, Quebec
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.