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

Primary Purpose

Cardiopulmonary Bypass, Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Heparin
cardiopulmonary bypass pump flow rate
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiopulmonary Bypass focused on measuring Heparin, Allogeneic blood product transfusions, Bleeding, Cardiac surgery, Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital LavalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Control group

Intervention group A

Intervention group B

Intervention group C

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Allogeneic transfusions of red blood cells
Percentage of subjects avoiding any allogeneic transfusions of red blood cells

Secondary Outcome Measures

Allogeneic transfusions of blood products
Percentage of subjects avoiding any allogeneic transfusions
Units of blood product transfusions
Number of units of transfused blood products
Massive red blood cell transfusions
Percentage of subjects avoiding massive red blood cell transfusion (more than 5 units)
Post-operative complications
Monitoring the safety of strategies by monitoring post-operative complications
Bleeding
Per- and post-operative bleeding

Full Information

First Posted
September 28, 2017
Last Updated
March 9, 2023
Sponsor
Laval University
Collaborators
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
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1. Study Identification

Unique Protocol Identification Number
NCT03302195
Brief Title
Optimal Cardiopulmonary Bypass and Anticoagulation Management Strategies in Obese Patients Undergoing Cardiac Surgery
Official Title
Optimal Cardiopulmonary Bypass and Anticoagulation Management Strategies in Obese Patients Undergoing Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2015 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiopulmonary Bypass, Obesity
Keywords
Heparin, Allogeneic blood product transfusions, Bleeding, Cardiac surgery, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control prospective trial
Masking
Participant
Masking Description
Participant is blinded to group assignment
Allocation
Randomized
Enrollment
410 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intervention group A
Arm Type
Experimental
Arm Description
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.
Arm Title
Intervention group B
Arm Type
Experimental
Arm Description
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.
Arm Title
Intervention group C
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Heparin
Intervention Description
Based on patient body weight (UI/kg)
Intervention Type
Procedure
Intervention Name(s)
cardiopulmonary bypass pump flow rate
Intervention Description
Based on patient body weight (L/min/m2)
Primary Outcome Measure Information:
Title
Allogeneic transfusions of red blood cells
Description
Percentage of subjects avoiding any allogeneic transfusions of red blood cells
Time Frame
Seven days post-operatively or until discharge, whichever comes first
Secondary Outcome Measure Information:
Title
Allogeneic transfusions of blood products
Description
Percentage of subjects avoiding any allogeneic transfusions
Time Frame
Seven days post-operatively or until discharge, whichever comes first
Title
Units of blood product transfusions
Description
Number of units of transfused blood products
Time Frame
Seven days post-operatively or until discharge, whichever comes first
Title
Massive red blood cell transfusions
Description
Percentage of subjects avoiding massive red blood cell transfusion (more than 5 units)
Time Frame
Seven days post-operatively or until discharge, whichever comes first
Title
Post-operative complications
Description
Monitoring the safety of strategies by monitoring post-operative complications
Time Frame
Post-operatively from day 0 up to first hospital discharge
Title
Bleeding
Description
Per- and post-operative bleeding
Time Frame
Peroperative, 4 and 24 hours post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hugo Tremblay, Bachelor
Phone
418-656-8711
Ext
3797
Email
hugo.tremblay@criucpq.ulaval.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Voisine, MD
Organizational Affiliation
University Laval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Laval
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugo Tremblay, Bachelor
Phone
418-656-8711
Ext
3797
Email
hugo.tremblay@criucpq.ulaval.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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