Influence of Oxygenator Selection on Platelet Function and Rotational Thromboelastometry Following Cardiopulmonary Bypass

April 12, 2026 updated by: BRADEN DULONG

Open-heart surgery requires temporarily stopping the heart and lungs and diverting the patient's blood to an outside system that takes over the function of the heart and lungs. This is possible through the use of cardiopulmonary bypass (CPB) which diverts blood, through plastic tubing, to a heart-lung machine which includes an oxygenator. The external oxygenator works as an artificial lung. This allows cardiac surgeons to operate in a field that is free of blood, while the patient's body continues to receive healthy blood.

CPB is an advanced medical technology that allows for heart surgeries, such as coronary artery bypass, heart valve surgery, and procedures involving major blood vessels. It is recognized that there are many risks associated with its use, including microscopic stress exerted on blood components by the oxygenator and tubing, which can lead to irreversible damage to the blood cells. This effect can contribute to bleeding during and after surgery. This type of bleeding can be difficult to monitor and treat, especially given the limited access to point-of-care blood testing to inform clinicians on what part of the blood is failing to function properly.

The investigators will use a point-of-care machine called Plateletworks to test the function of platelets during surgeries which require CPB. Platelets are an important part of blood that help stop bleeding by forming clots. At the investigators' institution two oxygenators are currently used interchangeably. These oxygenators have different properties that may impact how platelets function. This project will help determine if using a higher pressure oxygenator increases the risk of patients bleeding. Additionally, the investigators will compare the platelet data from Plateletworks to data collected from rotational thromboelastometry (ROTEM). This will yield valuable data about commonly used oxygenators and tests which can ultimately improve patient care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H3A7
        • Halifax Infirmary site, Queen Elizabeth II Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Scheduled for non emergent cardiac surgery
  • Anticipated long CPB time (Multi-vessel CABG, multi-valve surgeries, or combined CABG and valve procedures)

Exclusion Criteria:

  • Pregnancy
  • Age under 18 years on the surgery date
  • Weight less than 60kg
  • Any known pre-existing bleeding disorder
  • Inability to provide informed consent
  • Pre-existing abnormal fibrinogen level (normal: 1.8-4.7g/l)
  • Significant liver disease (alanine aminotransferase or aspartate aminotransferase > 150 U/l)
  • INR > 1.4
  • PTT greater than 38 (off IV heparin for 12h prior to testing)
  • Direct oral anticoagulant (DOAC) use within 72h preoperatively
  • Significant renal disease (eGFR < 50)
  • Emergency surgery
  • Intake of anti-platelet drugs (including ticagrelor and Plavix but excluding ASA) within three days (72h) preoperatively
  • Anemia (Hb < 110)
  • Deep vein thrombosis (DVT) (within 3 months prior to OR)
  • Pulmonary embolism (within 3 months prior to OR)
  • Stroke (within 3 months prior to OR)
  • Planned hypothermia below 28 degrees Celsius.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LivaNova Inspire
A high pressure oxygenator (LivaNova) will be used during cardiopulmonary bypass.
Device: LivaNova
A high pressure oxygenator (LivaNova) will be used during cardiopulmonary bypass.
Active Comparator: Terumo
A low pressure oxygenator (Terumo) will be used during cardiopulmonary bypass.
Device: Terumo
A low pressure oxygenator (Terumo) will be used during cardiopulmonary bypass.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plateletworks change in functional platelets
Time Frame: 24 hours from start of surgery (measured at the start and the end of cardiopulmonary bypass)
Change in functional platelets during cardiopulmonary bypass as measure by Plateletworks. ((Functional Platelets start - Functional Platelets end) / Functional Platelets start) *100%.
24 hours from start of surgery (measured at the start and the end of cardiopulmonary bypass)
Plateletworks functional platelet count
Time Frame: 24 hours from start of surgery (measured at the end of cardiopulmonary bypass)
Functional platelet count at the end of cardiopulmonary bypass as measured by Plateletworks.
24 hours from start of surgery (measured at the end of cardiopulmonary bypass)
Percentage of platelets which are functional at the end of cardiopulmonary bypass
Time Frame: 24 hours from start of surgery (measured at the end of cardiopulmonary bypass)
Percentage of platelets which are functional at the end of cardiopulmonary bypass as measured by Plateletworks.
24 hours from start of surgery (measured at the end of cardiopulmonary bypass)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ROTEM change in functional platelets
Time Frame: 24 hours from start of surgery (measured at the start and the end of cardiopulmonary bypass)
ROTEM platelet function = EXTEM A10 - FIBTEM A10. ROTEM change in functional platelets = ((ROTEM Functional Platelets start - ROTEM Functional Platelets end) / ROTEM Functional Platelets start) *100%.
24 hours from start of surgery (measured at the start and the end of cardiopulmonary bypass)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in functional platelets per unit time on cardiopulmonary bypass
Time Frame: 24 hours from start of surgery (measured at the start and the end of cardiopulmonary bypass)
Change in functional platelets per unit time on cardiopulmonary bypass for each oxygenator. As measured by Plateletworks. (Functional Platelets start - Functional Platelets end / time on cardiopulmonary bypass).
24 hours from start of surgery (measured at the start and the end of cardiopulmonary bypass)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BRADEN DULONG

Investigators

  • Principal Investigator: Braden Dulong, MD, Nova Scotia Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2022

Primary Completion (Actual)

October 31, 2025

Study Completion (Actual)

October 31, 2025

Study Registration Dates

First Submitted

October 6, 2022

First Submitted That Met QC Criteria

October 17, 2022

First Posted (Actual)

October 20, 2022

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 12, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NSH REB# 1027560

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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