Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT03302195

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

Led by Laval University · Updated on 2023-03-10

410

Participants Needed

1

Research Sites

645 weeks

Total Duration

On this page

Sponsors

L

Laval University

Lead Sponsor

C

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Obese patients with a body mass index (BMI) of 30 kg/m2 or higher
  • Planned cardiac surgery
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Having a permanent pacemaker
  • Known intolerance to protamine
  • Known or suspected allergy to the antifibrinolytic agent used
  • 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 below 28 degrees Celsius
  • Two or more cardiac surgery procedures planned
  • Emergency cardiac surgery within 24 hours of acute symptoms
  • Planned cardiopulmonary bypass priming with red blood cells
  • Any known autoimmune disease
  • History of stroke or non-coronary thrombotic disorders including deep venous thrombosis and pulmonary embolism
  • Significant carotid artery stenosis (50% or more)
  • Receiving low molecular weight Heparin less than 24 hours before surgery
  • Females of childbearing potential who are pregnant, breastfeeding, intend to become pregnant, or not using adequate contraception
  • Confirmed ST elevation myocardial infarction within 7 days
  • Pre-operative platelet count below 100,000 per microliter
  • Anemia defined as hematocrit below 32% for females or below 35% for males
  • Recent dosing with clopidogrel or ticagrelor within 5 days, or prasugrel within 7 days before surgery
  • Dosed with GPIIb/IIIa receptor blockers within 24 hours prior to surgery
  • International normalized ratio (INR) greater than 1.5 on surgery day for patients on vitamin K antagonists
  • Liver dysfunction with AST or ALT elevated at least twice above normal laboratory limits
  • Renal failure with creatinine 175 micromol/L or higher or on dialysis
  • Current thromboembolic disease other than myocardial infarction
  • Patients who have pre-donated autologous blood
  • Presenting with resistance to Heparin

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hopital Laval

Québec, Quebec, Canada, G1V 4G5

Actively Recruiting

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Research Team

H

Hugo Tremblay, Bachelor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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