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CPB Management & Anticoagulation for Obese Patients

N/A
Recruiting
Led By Pierre Voisine, MD
Research Sponsored by Laval University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Obese patients (BMI ≥ 30kg/m2)
Age ≥ 18 years
Must not have
Planned peri-operative use of desmopressin
Planned off pump coronary artery bypass
Timeline
Screening 3 weeks
Treatment Varies
Follow Up seven days post-operatively or until discharge, whichever comes first
Awards & highlights

Summary

This trial will help determine if using lean body mass to determine pump flow rate and/or heparin dosage is safe and effective for obese patients undergoing CPB.

Who is the study for?
This trial is for obese patients (BMI ≥ 30kg/m2) who are at least 18 years old and scheduled for cardiac surgery with cardiopulmonary bypass. It's not suitable for those with allergies to anticoagulants like Heparin, severe kidney or liver issues, certain blood disorders, recent heart attacks or strokes, or women who are pregnant/breastfeeding.Check my eligibility
What is being tested?
The study tests if calculating the flow rate of the cardiopulmonary bypass pump and Heparin dosage based on lean body mass instead of total weight is safe and effective in obese patients undergoing heart surgery.See study design
What are the potential side effects?
Potential side effects may include bleeding complications due to Heparin use, reactions related to incorrect dosing affecting organ function, and possible intolerance to protamine used during surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My BMI is 30 or higher.
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I am 18 years old or older.
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I am scheduled for heart surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I will be using desmopressin around the time of my surgery.
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I am scheduled for a heart bypass surgery without using a heart-lung machine.
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I am scheduled for a procedure that involves cooling my body and stopping my blood circulation.
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My liver tests (AST or ALT) are not more than 2 times the normal limit.
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I have a known inherited bleeding disorder.
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I have a major narrowing (50% or more) in my carotid artery.
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I refuse to receive blood transfusions.
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I have a known deficiency in protein C, S, antithrombin, or have homozygous factor V Leiden.
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I have an infection in the heart's inner lining.
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I have had two or more heart surgeries.
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I need emergency heart surgery within 24 hours due to acute symptoms.
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My surgery will use my own blood to prime the heart-lung machine.
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I am not pregnant, breastfeeding, planning to become pregnant, or failing to use birth control.
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I had a major heart attack within the last week.
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My blood clotting time is longer due to my medication.
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I have kidney failure or am on dialysis.
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I have a blood clot condition that is not a heart attack.
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I am resistant to Heparin.
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I have a history of stroke or blood clots, including in my legs or lungs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~peroperative, 4 and 24 hours post-operative
This trial's timeline: 3 weeks for screening, Varies for treatment, and peroperative, 4 and 24 hours post-operative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Allogeneic transfusions of red blood cells
Secondary outcome measures
Allogeneic transfusions of blood products
Bleeding
Massive red blood cell transfusions
+2 more

Side effects data

From 2008 Phase 4 trial • 541 Patients • NCT00277394
9%
Urinary tract infection
8%
Haematoma
6%
Constipation
4%
Pain in extremity
4%
Diarrhoea
2%
Deep vein thrombosis
2%
Cardiac failure
1%
International normalised ratio increased
1%
Melaena
1%
Subcutaneous haematoma
1%
Coagulation time prolonged
1%
Left ventricular failure
1%
Multi-organ failure
1%
Fall
1%
Sudden death
1%
Death
1%
General physical health deterioration
1%
Lung neoplasm malignant
1%
Metastatic neoplasm
1%
Respiratory failure
1%
Pulmonary embolism
1%
Depression
1%
Anaemia
1%
Rectal haemorrhage
1%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Innohep®
Heparin

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Intervention group CExperimental Treatment2 Interventions
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.
Group II: Intervention group BExperimental Treatment2 Interventions
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.
Group III: Intervention group AExperimental Treatment2 Interventions
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.
Group IV: Control groupActive Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Heparin
FDA approved

Find a Location

Who is running the clinical trial?

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de QuebecOTHER
36 Previous Clinical Trials
9,325 Total Patients Enrolled
1 Trials studying Obesity
120 Patients Enrolled for Obesity
Laval UniversityLead Sponsor
422 Previous Clinical Trials
172,436 Total Patients Enrolled
32 Trials studying Obesity
15,882 Patients Enrolled for Obesity
Pierre Voisine, MDPrincipal InvestigatorUniversity Laval
2 Previous Clinical Trials
391 Total Patients Enrolled

Media Library

Heparin Clinical Trial Eligibility Overview. Trial Name: NCT03302195 — N/A
Obesity Research Study Groups: Control group, Intervention group A, Intervention group B, Intervention group C
Obesity Clinical Trial 2023: Heparin Highlights & Side Effects. Trial Name: NCT03302195 — N/A
Heparin 2023 Treatment Timeline for Medical Study. Trial Name: NCT03302195 — N/A
Obesity Patient Testimony for trial: Trial Name: NCT03302195 — N/A
~18 spots leftby Dec 2024