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

March 9, 2023 updated by: Pierre Voisine, Laval University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
410

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Quebec City, Quebec, Canada, G1V 4G5
        • Recruiting
        • Hôpital Laval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Heparin
Based on patient body weight (UI/kg)
Procedure: cardiopulmonary bypass pump flow rate
Based on patient body weight (L/min/m2)
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.
Drug: Heparin
Based on patient body weight (UI/kg)
Procedure: cardiopulmonary bypass pump flow rate
Based on patient body weight (L/min/m2)
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.
Drug: Heparin
Based on patient body weight (UI/kg)
Procedure: cardiopulmonary bypass pump flow rate
Based on patient body weight (L/min/m2)
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.
Drug: Heparin
Based on patient body weight (UI/kg)
Procedure: cardiopulmonary bypass pump flow rate
Based on patient body weight (L/min/m2)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Seven days post-operatively or until discharge, whichever comes first

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Allogeneic transfusions of blood products
Time Frame: Seven days post-operatively or until discharge, whichever comes first
Percentage of subjects avoiding any allogeneic transfusions
Seven days post-operatively or until discharge, whichever comes first
Units of blood product transfusions
Time Frame: Seven days post-operatively or until discharge, whichever comes first
Number of units of transfused blood products
Seven days post-operatively or until discharge, whichever comes first
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)
Seven days post-operatively or until discharge, whichever comes first
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
Post-operatively from day 0 up to first hospital discharge
Bleeding
Time Frame: Peroperative, 4 and 24 hours post-operative
Per- and post-operative bleeding
Peroperative, 4 and 24 hours post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laval University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 21, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Obesity-CPB-21117

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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