Recruiting

Cardiac Surgery

Sponsor:

Laval University

Code:

NCT03302195

Conditions

Cardiopulmonary Bypass

Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Heparin

cardiopulmonary bypass pump flow rate

Study Details

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.

Conditions

Cardiopulmonary Bypass

Obesity

Study ID

NCT03302195

Start date

Aug 21, 2015

Status verified date

Mar, 2023

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

410 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control group

Heparin dose and cardiopulmonary bypass pump flow rate are calculated using total body weight.

An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated.

experimental: Intervention group A

Heparin dose is adjusted for lean body weight and cardiopulmonary bypass pump flow rate is calculated using total body weight.

An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated.

experimental: Intervention group B

Heparin dose is calculated using total body weight and cardiopulmonary bypass pump flow rate is adjusted for lean body weight.

An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated.

experimental: Intervention group C

Heparin dose and cardiopulmonary bypass pump flow rate are adjusted for lean body weight.

An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated.

Interventions

Heparin

Based on patient body weight (UI/kg)

cardiopulmonary bypass pump flow rate

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

Primary outcome measure

  • Allogeneic transfusions of red blood cells [ Time Frame: Seven days post-operatively or until discharge, whichever comes first ]

Central Contacts and Locations

Central contacts

Hugo Tremblay, Bachelor

418-656-8711hugo.tremblay@criucpq.ulaval.ca

Locations

Hopital Laval

Recruiting

Quebec City, Quebec, Canada, G1V 4G5

Contacts

Hugo Tremblay, Bachelor

418-656-8711hugo.tremblay@criucpq.ulaval.ca

More Information

Sponsor

Laval University

Last update posted

Mar 10, 2023

Last verified

Mar, 2023

Keywords

  • Heparin
  • Allogeneic blood product transfusions
  • Bleeding
  • Cardiac surgery
  • Obesity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2023-03-10.