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

NCT05588011 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-04-15

No results posted yet for this study

Summary

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.

Conditions

  • Platelet Dysfunction
  • Cardiopulmonary Bypass

Interventions

DEVICE

Terumo

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

DEVICE

LivaNova

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

Sponsors & Collaborators

  • BRADEN DULONG

    lead OTHER

Principal Investigators

  • Braden Dulong, MD · Nova Scotia Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-07
Primary Completion
2025-10-31
Completion
2025-10-31
FDA Device
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05588011 on ClinicalTrials.gov