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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

Approved for 20 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ peroperative, 4 and 24 hours post-operative

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Allogeneic transfusions of red blood cells

Secondary study objectives

Allogeneic transfusions of blood products

Bleeding

Massive red blood cell transfusions

+2 more

Side effects data

From 2008 Phase 4 trial • 541 Patients • NCT00277394

Urinary tract infection

Haematoma

Constipation

Diarrhoea

Pain in extremity

Cardiac failure

Deep vein thrombosis

Subcutaneous haematoma

Left ventricular failure

Melaena

General physical health deterioration

Sudden death

Multi-organ failure

Death

Fall

Coagulation time prolonged

Metastatic neoplasm

International normalised ratio increased

Lung neoplasm malignant

Depression

Respiratory failure

Pulmonary embolism

Anaemia

Rectal haemorrhage

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Innohep®

Heparin

Awards & Highlights

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 22Eligibility criteria met