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Oxygenator Selection for Cardiopulmonary Bypass
N/A
Recruiting
Led By Braden Dulong, MD
Research Sponsored by BRADEN DULONG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours from start of surgery (measured at the end of cardiopulmonary bypass)
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the effects of a heart-lung machine on platelet function to determine if they increase the risk of patients bleeding during/after open-heart surgery.
Who is the study for?
Adults scheduled for non-emergency heart surgery with expected long cardiopulmonary bypass times can join. Excluded are those under 18, with bleeding disorders, recent clots or strokes, severe kidney/liver disease, anemia, on certain blood thinners recently (except ASA), pregnant women, and anyone unable to consent.
What is being tested?
The trial is testing if different oxygenators used in heart-lung machines during open-heart surgery affect platelet function and clotting. It compares Terumo and LivaNova oxygenators using Plateletworks tests and rotational thromboelastometry to assess patient bleeding risks.
What are the potential side effects?
There may not be direct side effects from the interventions as this study focuses on equipment used during surgery rather than medications. However, there's a potential risk of increased bleeding due to altered platelet function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours from start of surgery (measured at the end of cardiopulmonary bypass)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours from start of surgery (measured at the end of cardiopulmonary bypass)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Blood Platelets
Blood Platelets
Platelet Count measurement
Secondary study objectives
ROTEM change in functional platelets
Other study objectives
Cardiopulmonary Bypass
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: LivaNova InspireActive Control1 Intervention
A high pressure oxygenator (LivaNova) will be used during cardiopulmonary bypass.
Group II: TerumoActive Control1 Intervention
A low pressure oxygenator (Terumo) will be used during cardiopulmonary bypass.
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Who is running the clinical trial?
BRADEN DULONGLead Sponsor
Braden DulongLead Sponsor
Braden Dulong, MDPrincipal InvestigatorNova Scotia Health
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I will be younger than 18 years old on the day of my surgery.I have had emergency surgery.I have not had a pulmonary embolism in the last 3 months.I weigh less than 60kg.My kidney function is low (eGFR < 50).I have not had a stroke in the last 3 months.I am scheduled for a treatment that involves cooling my body below 28 degrees Celsius.I have had a deep vein thrombosis in the last 3 months.My liver is functioning well (liver enzymes are not too high).I have a known bleeding disorder.I have taken blood thinners within 3 days before surgery.I am scheduled for a planned heart surgery.I am expected to have a long heart-lung machine use due to complex heart surgery.I haven't taken any anti-platelet drugs except for ASA in the last 3 days.
Research Study Groups:
This trial has the following groups:- Group 1: LivaNova Inspire
- Group 2: Terumo
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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