Optimal Cardiopulmonary Bypass and Anticoagulation Management Strategies in Obese Patients Undergoing Cardiac Surgery
1 other identifier
interventional
410
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 21, 2015
CompletedFirst Submitted
Initial submission to the registry
September 28, 2017
CompletedFirst Posted
Study publicly available on registry
October 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
ExpectedMarch 10, 2023
March 1, 2023
9.4 years
September 28, 2017
March 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Allogeneic transfusions of red blood cells
Percentage of subjects avoiding any allogeneic transfusions of red blood cells
Seven days post-operatively or until discharge, whichever comes first
Secondary Outcomes (5)
Allogeneic transfusions of blood products
Seven days post-operatively or until discharge, whichever comes first
Units of blood product transfusions
Seven days post-operatively or until discharge, whichever comes first
Massive red blood cell transfusions
Seven days post-operatively or until discharge, whichever comes first
Post-operative complications
Post-operatively from day 0 up to first hospital discharge
Bleeding
Peroperative, 4 and 24 hours post-operative
Study Arms (4)
Control group
ACTIVE COMPARATORHeparin 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.
Intervention group A
EXPERIMENTALHeparin 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.
Intervention group B
EXPERIMENTALHeparin 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.
Intervention group C
EXPERIMENTALHeparin 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
Based on patient body weight (UI/kg)
Based on patient body weight (L/min/m2)
Eligibility Criteria
You may qualify if:
- Obese patients (BMI ≥ 30kg/m2)
- Planned cardiac surgery
- Age ≥ 18 years
You may not qualify if:
- 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
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hopital Laval
Québec, Quebec, G1V 4G5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre Voisine, MD
University Laval
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participant is blinded to group assignment
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Cardiac surgeon
Study Record Dates
First Submitted
September 28, 2017
First Posted
October 5, 2017
Study Start
August 21, 2015
Primary Completion
December 31, 2024
Study Completion (Estimated)
December 31, 2027
Last Updated
March 10, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share