Comparing blood cell damage in two types of heart-lung machines in patients undergoing open-heart surgery
| ISRCTN | ISRCTN11514932 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11514932 |
| Secondary identifying numbers | NL59160.015.16 |
- Submission date
- 18/11/2020
- Registration date
- 09/12/2020
- Last edited
- 09/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Scientific
Molengracht 21
Breda
48181CK
Netherlands
 ORCID ID |
0000-0003-2264-4352 |
|---|---|
| Phone | +31 (0)765955126 |
| dhoogzaad@amphia.nl |
Study information
| Study design | Single-center prospective randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN11514932_PIS_Dutch.doc |
| Scientific title | Hemolysis and cell death in conventional versus miniaturized cardiopulmonary bypass systems |
| Study acronym | ECCiH study |
| Study objectives | The MiECC system induces less hemolysis and cell death than the CECC system |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/09/2016 |
| Completion date | 11/05/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 19/09/2017 |
| Date of final enrolment | 15/03/2018 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Breda
4818CK
Netherlands
Sponsor information
Hospital/treatment centre
Molengracht 21
Breda
4818CK
Netherlands
| Phone | +31 (0)76 595 1508 |
|---|---|
| BGerritse@amphia.nl | |
| Website | http://www.amphia.nl/Pages/default.aspx |
"ROR" |
https://ror.org/01g21pa45 |
Funders
Funder type
Hospital/treatment centre
No information available
No information available
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 04/01/2021 | No | Yes |
Additional files
- ISRCTN11514932_PIS_Dutch.doc
- Uploaded 04/01/2021
Editorial Notes
09/07/2021: The intention to publish date has been changed from 31/01/2021 to 31/12/2021.
04/01/2021: The participant information sheet has been uploaded.
01/12/2020: Trial’s existence confirmed by Medisch ethische toetsingscommissie Maxima medisch centrum
