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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up seven days post-operatively or until discharge, whichever comes first
Awards & highlights

Study 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.

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%
Diarrhoea
4%
Pain in extremity
2%
Deep vein thrombosis
2%
Cardiac failure
1%
International normalised ratio increased
1%
Pulmonary embolism
1%
Respiratory failure
1%
Melaena
1%
Subcutaneous haematoma
1%
Anaemia
1%
Left ventricular failure
1%
Rectal haemorrhage
1%
Death
1%
General physical health deterioration
1%
Multi-organ failure
1%
Sudden death
1%
Sepsis
1%
Fall
1%
Coagulation time prolonged
1%
Lung neoplasm malignant
1%
Metastatic neoplasm
1%
Depression
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
9,332 Total Patients Enrolled
1 Trials studying Obesity
120 Patients Enrolled for Obesity
Laval UniversityLead Sponsor
416 Previous Clinical Trials
171,866 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What additional investigations have been conducted on the use of Heparin?

"To date, 36 clinical trials have been launched to investigate the efficacy of Heparin. 12 of these studies are currently in their final phase and 367 sites across the world are conducting research on this medication, with a concentration around Sherbrooke, Quebec."

Answered by AI

Is enrollment for this experiment currently available?

"Indeed, current data from clinicaltrials.gov confirms that this research project is presently enrolling participants. The trial was first posted on August 21st 2015 and updated most recently on August 18th 2022. A total of 410 individuals need to be enrolled at one medical centre."

Answered by AI

What ailments is Heparin regularly employed to combat?

"Heparin is often utilized to treat medical equipment, but also has a range of therapeutic applications including treating sprains, atrial fibrillation, and unstable angina pectoris."

Answered by AI

Is this an innovative research endeavor?

"Heparin has been studied since 2006, with the first trial conducted by Ash Access Technology. After 415 participants completed Phase 1 of this research, it received its drug approval and currently 36 trials are in progress across 197 cities and 21 countries."

Answered by AI

What is the total number of participants currently being recruited for this trial?

"Affirmative. Clinicaltrials.gov data shows that the trial posted on August 21st 2015 is currently attempting to recruit 410 participants from 1 site."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
Texas
Arizona
How old are they?
65+
What site did they apply to?
Hopital Laval
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have tried other weight loss programs and the weight keeps returning. I have tried other methods (OTC,prescription, thherapy etc) to reduce weight but afte about 10-15% loss...it has stabilized at 230 lbs/BMI 36.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

It is far away from Cleveland. How many times to I have to be seen?
PatientReceived no prior treatments
~33 spots leftby Dec 2024