Condition category
Surgery
Date applied
18/11/2020
Date assigned
09/12/2020
Last edited
04/01/2021
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

http://www.amphia.nl/Pages/default.aspx

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

Editorial Notes

04/01/2021: The participant information sheet has been uploaded. 01/12/2020: Trial’s existence confirmed by Medisch ethische toetsingscommissie Maxima medisch centrum