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Recruiting

NCT Number: NCT03302195

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Laval

Québec, Quebec, G1V 4G5, Canada

Location status: Recruiting

Location contact

Hugo Tremblay, Bachelor

CONTACT

[email protected]

418-656-8711 ext. 3797

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heparin

Drug

Based on patient body weight (UI/kg)

cardiopulmonary bypass pump flow rate

Procedure

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

Primary outcomes

  1. Allogeneic transfusions of red blood cells

    Time frame: Seven days post-operatively or until discharge, whichever comes first

    Percentage of subjects avoiding any allogeneic transfusions of red blood cells

Secondary outcomes

  1. Allogeneic transfusions of blood products

    Time frame: Seven days post-operatively or until discharge, whichever comes first

    Percentage of subjects avoiding any allogeneic transfusions

  2. Units of blood product transfusions

    Time frame: Seven days post-operatively or until discharge, whichever comes first

    Number of units of transfused blood products

  3. Massive red blood cell transfusions

    Time frame: Seven days post-operatively or until discharge, whichever comes first

    Percentage of subjects avoiding massive red blood cell transfusion (more than 5 units)

  4. Post-operative complications

    Time frame: Post-operatively from day 0 up to first hospital discharge

    Monitoring the safety of strategies by monitoring post-operative complications

  5. Bleeding

    Time frame: Peroperative, 4 and 24 hours post-operative

    Per- and post-operative bleeding

Study contacts

Contact information is provided by the study sponsor or research team.

Hugo Tremblay, Bachelor

CONTACT

[email protected]

418-656-8711 ext. 3797

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Registry information

Important dates

Study start
2015
Primary completion
2024
Study completion
2027
First posted
Oct 5, 2017
Registry last updated
Mar 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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