Oxygenator Selection for Cardiopulmonary Bypass

Overseen By Taryn Forrestall

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: BRADEN DULONG

Must not be taking: Direct oral anticoagulants, Antiplatelet drugs

Disqualifiers: Pregnancy, Bleeding disorder, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores different oxygenators used during open-heart surgery to assess their impact on blood clotting. A special testing machine checks platelets, which help stop bleeding. The trial compares two types of oxygenators—one high pressure and one low pressure—to determine if they affect bleeding risks differently. Individuals scheduled for non-emergency heart surgery with expected prolonged use of a heart-lung machine (cardiopulmonary bypass) might be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to contribute to medical knowledge and potentially improve surgical outcomes for future patients.

Will I have to stop taking my current medications?

The trial requires that you stop taking direct oral anticoagulants (DOACs) and certain anti-platelet drugs, like ticagrelor and Plavix, at least 72 hours before surgery. However, aspirin (ASA) is allowed. Please consult with your doctor for specific guidance on your medications.

What prior data suggests that these oxygenators are safe for use in cardiopulmonary bypass?

In previous studies, both the LivaNova Inspire and Terumo oxygenators have been used in surgeries where the heart and lungs are temporarily stopped, with these devices taking over their functions.

Research has shown that the LivaNova Inspire oxygenator works reliably and controls gas exchange well. However, some reports noted device failures during use, requiring patients to be taken off bypass briefly. This is crucial for safety, as it can affect blood flow and oxygen delivery during surgery.

The Terumo oxygenator has also undergone safety studies. Some reports highlighted issues with gas exchange, indicating it sometimes did not manage gases like carbon dioxide in the blood effectively. However, changing the oxygenator resolved these issues, significantly improving the situation.

Both oxygenators are approved for use in surgeries requiring CPB, but like any medical device, they have pros and cons. Awareness of these potential issues is important, as they can impact the safety and outcome of the procedure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Oxygenator Selection for Cardiopulmonary Bypass trial because it explores the impact of using different oxygenators during surgery. The two oxygenators being tested, LivaNova Inspire and Terumo, have distinct pressure profiles—high pressure for LivaNova and low pressure for Terumo. By comparing these oxygenators, the trial aims to uncover which provides better outcomes for patients undergoing cardiopulmonary bypass, potentially leading to improved safety and effectiveness during surgery. Understanding these differences could enhance patient care by optimizing oxygen delivery during critical procedures.

What evidence suggests that these oxygenators are effective for cardiopulmonary bypass?

In this trial, participants will join one of two treatment arms to evaluate different oxygenators used during cardiopulmonary bypass. Participants in one arm may receive the LivaNova Inspire oxygenator, which previous studies have shown effectively controls tiny bubbles in the blood and provides consistent oxygen levels during surgery. This helps maintain healthy blood during the operation. Participants in the other arm will receive the Terumo oxygenator, known for reducing the risk of blood dilution, potentially leading to better patient outcomes. Both oxygenators effectively maintain proper blood function during surgery, but they differ in their impact on platelets, which are crucial for blood clotting and reducing bleeding. These differences might influence their effectiveness during heart surgeries. ^{1 6 7 8 9}

Who Is on the Research Team?

Braden Dulong, MD

Principal Investigator

Nova Scotia Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am scheduled for a planned heart surgery.

I am expected to have a long heart-lung machine use due to complex heart surgery.

Exclusion Criteria

Pregnancy

INR > 1.4

PTT greater than 38 (off IV heparin for 12h prior to testing)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cardiopulmonary bypass surgery using either a high pressure or low pressure oxygenator, with platelet function monitored using Plateletworks and ROTEM

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in platelet function and potential bleeding complications post-surgery

24 hours

What Are the Treatments Tested in This Trial?

Interventions

• Cardiopulmonary Bypass
• LivaNova
• Terumo

Trial Overview 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.

How Is the Trial Designed?

Group I: LivaNova Inspire Active Control 1 Intervention

A high pressure oxygenator (LivaNova) will be used during cardiopulmonary bypass.

Group II: Terumo Active Control 1 Intervention

A low pressure oxygenator (Terumo) will be used during cardiopulmonary bypass.

Who Is Running the Clinical Trial?

BRADEN DULONG

Lead Sponsor

Trials

1

Recruited

70+

Braden Dulong

Lead Sponsor

Trials

1

Recruited

70+

Citations

1. livanova.com livanova.com/cardiopulmonary/en-us/oxygenators/inspire

Inspire Oxygenator for CPB | LivaNova US Inspire oxygenators have a large range of flow sizes for adult cardiopulmonary bypass. They offer consistent performance, low DOV and effective GME control.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5737430/

An In-Vitro Study Comparing the GME Handling of Two ... The Inspire with an arterial filter was more efficient in removing GME during a 60 mL bolus and 1 LPM than the Fusion and Fusion with an arterial filter.

3. jcardcritcare.org jcardcritcare.org/content/149/2025/9/3/pdf/JCCC-9-171.pdf

Comparative Assessment of Membrane Oxygenator ... Our study demonstrated that both the Nipro Vital and Sorin Inspire oxygenators were equally effective in maintaining oxygenation, thus ...

4. assets.livanova.com assets.livanova.com/media/com/documents/therapeutic%20areas/cardiopulmonary/brochures/livanova_inspire_8_broch_09295-130-b.pdf?ext=.pdf

INSPIRETM 8 PH.I.S.I.O. Minimizing hemodilution contributes to decreased blood transfusions and improved clinical outcomes during and after cardiopulmonary bypass (CPB). Until now ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666273623003066

Initial experience and outcomes with a hybrid ... This study describes our initial experience and outcomes in the first 100 bilateral lung transplantations using this novel hybrid VA-ECMO/CPB circuit.

6. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=11027141&pc=DTZ

MAUDE Adverse Event Report: LIVANOVA USA INSPIRE ... Oxygenator failed: while the patient was on bypass, the heart lung machine oxygenator failed, the patient had to come off bypass for three minutes and the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10775128/

Initial experience and outcomes with a hybrid extracorporeal ... Of the 100 patients supported with VA-ECMO, 19 were converted intraoperatively to CPB. Right ventricular dysfunction was seen in 37% of patients, and the median ...

8. livanova.com livanova.com/cardiopulmonary/getmedia/e305bc44-995e-4b27-8848-d0ca2d89a6ae/7_ous_faq-for-fsn-on-3t-compatibility-with-polymer-he_im-00727a.pdf

Frequently Asked Questions (FAQs) Regarding Use of ... LivaNova has performed in vitro testing using water (worst case situation) and bovine blood for the evaluation of hydrogen peroxide diffusion across the Inspire ...

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf18/K180448.pdf

INSPIRE 6F M Hollow Fiber Oxygen - accessdata.fda.gov INSPIRE 6F M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support ...