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Comparing blood cell damage in two types of heart-lung machines in patients undergoing open-heart surgery

Hemolysis and cell death in conventional versus miniaturized cardiopulmonary bypass systems

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11514932
Enrollment
40
Registered
2020-12-09
Start date
2017-09-19
Completion date
Unknown
Last updated
2021-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing coronary artery bypass grafting with cardiopulmonary bypass Surgery

Interventions

Patients that required planned CABG surgery were randomly assigned for inclusion in one of two groups: (1) patients maintained by Conventional extracorporeal circulation system (n=20), (2) patients m

Sponsors

Amphia Ziekenhuis
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Elective isolated CABG surgery with CPB at Amphia hospital 2. Male or female =18 years 3. The graft material used could be the: left internal mammary artery (LIMA), Right internal mammary artery (RIMA), Saphenous vein or Radial artery

Exclusion criteria

Exclusion criteria: 1. The creatinine level >150µmol/L 2. Aspartate transaminase (ASAT) level >80 U/L 3. Ejection Fraction (EF) <30% 4. BSA <1.6, =2.5m² 5. Carotid artery stenosis 6. Hemoglobin level <7.5, =10 mmol/L 7. Pre-operative red blood cell transfusion, <14 days before CABG procedure

Design outcomes

Primary

MeasureTime frame
Hemolysis was measured using free Hb and LDH as parameters. Blood was obtained at baseline, at 5 and 30 min, 10 min after clamp removal, post ECC and post-surgery at the intensive care unit (ICU)

Secondary

MeasureTime frame
Cell death and neutrophil activation were measured using nucleosome and HNE-a1-ATc ELISA's. Blood was obtained at baseline, at 5 and 30 min, 10 min after clamp removal, post ECC and post-surgery at the intensive care unit (ICU)

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026