Effects of oxygenator choice on blood platelet function during heart surgery
Influence of Oxygenator Selection on Platelet Function and Rotational Thromboelastometry Following Cardiopulmonary Bypass
This study is testing whether using different types of oxygenators during heart surgery affects how well blood platelets work and if it can lead to complications like bleeding.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nova Scotia Health Authority Academic / other |
| Locations | 1 site (Halifax, Nova Scotia) |
| Trial ID | NCT05588011 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates how the selection of different oxygenators affects platelet function and blood coagulation during cardiopulmonary bypass (CPB) in patients undergoing open-heart surgery. The study aims to understand the impact of oxygenator-induced stress on blood components, which can lead to complications such as bleeding. Patients scheduled for non-emergent cardiac surgeries with anticipated long CPB times will be enrolled to assess the outcomes related to platelet function using specific tests. The trial will compare the effects of two types of oxygenators, Terumo and LivaNova, on patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults scheduled for non-emergent cardiac surgeries with expected long cardiopulmonary bypass times.
Not a fit: Patients with pre-existing bleeding disorders, significant liver or renal disease, or those undergoing emergency surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of platelet function during heart surgeries, potentially reducing bleeding complications.
How similar studies have performed: While there have been studies on the effects of oxygenators in CPB, this specific approach focusing on platelet function is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Halifax, Nova Scotia
- Halifax Infirmary site, Queen Elizabeth II Health Sciences Centre — Halifax, Nova Scotia, Canada (Recruiting)
Study contacts
- Principal investigator: Braden Dulong, MD — Nova Scotia Health
- Study coordinator: Braden Dulong, MD
- Email: braden.dulong@nshealth.ca
- Phone: 19024732331
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.