Plain English Summary
Background and study aims
Coronary artery bypass grafting (CABG) is a type of heart surgery used to treat coronary heart disease. It diverts blood around narrowed or clogged parts of the major arteries to improve blood flow and oxygen supply to the heart.
During heart surgery, the vital functions are maintained by a heart-lung machine. Heart-lung machines are known to cause blood cell damage. The aim of this study was to compare the amount of blood cell damage caused by two different types of heart-lung machines. Both heart-lung machines are used on a daily basis. This study will support future decision making of which type of heart-lung machine should be used during an operation.
Who can participate?
Patients scheduled to undergo coronary artery bypass grafting (CABG) surgery.
What does the study involve?
Participants were randomly allocated to one of two types of heart-lung machine. Blood samples were taken at 6 points in time after the induction of anesthesia. Per patient a total of 72 mL blood was collected through the central line or from the heart-lung machine and patients did not undergo extra interventions for this study.
What are the possible benefits and risks of participating?
For each individual patient no benefits or risks were involved by performing this study.
Where is the study run from?
Amphia Hospital in Breda (Netherlands)
When is the study starting and how long is it expected to run for?
September 2016 to May 2018
Who is funding the study?
1. Amphia Hospital (Netherlands)
2. Sanquin Amsterdam (Netherlands)
Who is the main contact?
Denise Hoogzaad, dhoogzaad@amphia.nl
Trial website
Contact information
Type
Scientific
Primary contact
Ms Denise Hoogzaad
ORCID ID
http://orcid.org/0000-0003-2264-4352
Contact details
Molengracht 21
Breda
48181CK
Netherlands
+31 (0)765955126
dhoogzaad@amphia.nl
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
NL59160.015.16
Study information
Scientific title
Hemolysis and cell death in conventional versus miniaturized cardiopulmonary bypass systems
Acronym
ECCiH study
Study hypothesis
The MiECC system induces less hemolysis and cell death than the CECC system
Ethics approval
Approved 23/01/2017, Medisch ethische toetsingscommissie Maxima medisch centrum (De Run 4600, 5504 DB Veldhoven, Netherlands; +31 (040) 888 95 28; metc@mmc.nl), ref: W16.122
Study design
Single-center prospective randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
See additional files (in Dutch)
Condition
Patients undergoing coronary artery bypass grafting with cardiopulmonary bypass
Intervention
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 maintained by MiECC (n=20).
Samples were collected in the operation theater and in the ICU. In the ICU, samples were collected 2,5-3 hours after weaning from ECC and administration of protamine. There was no further follow-up for the included patients. We used the program Castor for the randomization process.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
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 outcome measures
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)
Overall trial start date
01/09/2016
Overall trial end date
11/05/2018
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Total final enrolment
40
Participant 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
Recruitment start date
19/09/2017
Recruitment end date
15/03/2018
Locations
Countries of recruitment
Netherlands
Trial participating centre
Amphia hospital
Molengracht 21
Breda
4818CK
Netherlands
Sponsor information
Organisation
Amphia Ziekenhuis
Sponsor details
Molengracht 21
Breda
4818CK
Netherlands
+31 (0)76 595 1508
BGerritse@amphia.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Amphia Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Sanquin Amsterdam
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available.
Intention to publish date
31/01/2021
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN11514932_PIS_Dutch.doc Uploaded 04/01/2021