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

Launched by BRADEN DULONG · Oct 17, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how different types of oxygenators, which are used in heart surgeries, affect the function of platelets in the blood. Platelets are small cells that help stop bleeding by forming clots, and they can be impacted during surgeries that require a procedure called cardiopulmonary bypass (CPB), where a machine temporarily takes over the work of the heart and lungs. The researchers want to find out if using a specific type of oxygenator increases the risk of bleeding for patients undergoing heart surgery.

To be eligible for this trial, participants must be scheduled for non-emergency heart surgery that is expected to take a long time on the CPB machine. They should be between 18 and 74 years old and should not have any significant bleeding disorders or other serious health conditions that could complicate the surgery. During the trial, participants will have their platelet function tested using a special machine while undergoing surgery, which will help doctors understand how different oxygenators affect bleeding risks. This information could lead to better care for patients in the future.

Gender

ALL

Eligibility 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.