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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03302195
• Other study ID #: Obesity-CPB-21117
• Status: Recruiting
• Phase: N/A
• Start date: August 21, 2015
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2023
• Source: Laval University
• Contact: Hugo Tremblay, Bachelor
• Phone: 418-656-8711
• Email: hugo.tremblay[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 410
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiopulmonary Bypass
• Obesity

Intervention

Drug:
• Heparin
Based on patient body weight (UI/kg)

Procedure:
• cardiopulmonary bypass pump flow rate
Based on patient body weight (L/min/m2)

Locations

Country	Name	City	State
Canada	Hopital Laval	Quebec City	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Allogeneic transfusions of red blood cells	Percentage of subjects avoiding any allogeneic transfusions of red blood cells	Seven days post-operatively or until discharge, whichever comes first
Secondary	Allogeneic transfusions of blood products	Percentage of subjects avoiding any allogeneic transfusions	Seven days post-operatively or until discharge, whichever comes first
Secondary	Units of blood product transfusions	Number of units of transfused blood products	Seven days post-operatively or until discharge, whichever comes first
Secondary	Massive red blood cell transfusions	Percentage of subjects avoiding massive red blood cell transfusion (more than 5 units)	Seven days post-operatively or until discharge, whichever comes first
Secondary	Post-operative complications	Monitoring the safety of strategies by monitoring post-operative complications	Post-operatively from day 0 up to first hospital discharge
Secondary	Bleeding	Per- and post-operative bleeding	Peroperative, 4 and 24 hours post-operative