Contact information
Type
Scientific
Primary contact
Dr J.A.M. Hagenaars
ORCID ID
Contact details
Universitair Medisch Centrum Groningen
Department of Anesthesiology
Hanzeplein 1
P.O. Box 30001
Groningen
9700 RB
Netherlands
+31 (0)50 3612341
j.a.m.hagenaars@anest.umcg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR244
Study information
Scientific title
The clinical effects of leukocyte removal filters, cell savers and their combination on blood transfusion and organ damage during cardiac surgery
Acronym
filterstudie
Study hypothesis
We hypothesise that the application of a leukocyte depletion filter for surgical wound blood will reduce organ damage and coagulation disorders through removal of activated leukocytes and other particles.
We expect that the efficacy of a cell saver combined with a leukocyte filter increases by reduction of allogenic blood transfusions and organ damage.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Multicentre randomised unblinded active-controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
transfusion complications, organ damage, coagulation disorders
Intervention
The patients will be divided in 4 groups according to a randomisation table:
1. In group I (n = 150) blood will be processed with a cell saver and transfused without leukocyte removal filter
2. In group II (n = 150) blood will be processed with a cell saver and transfused through a leukocyte removal filter
3. In group III (n = 150) blood will be filtered with a leukocyte removal filter, but not be processed with a cell saver. The surgical wound suction blood before, during and after cardiopulmonary bypass and the residual heart lung machine blood will be collected in a separate cardiotomy reservoir and filtered with a leukocyte removal filter.
4. In group IV (n = 150) blood will be transfused without filter and without cell saver. The wound suction blood before and after cardiopulmonary bypass will be discarded, which is at this moment routine practice. The wound suction blood during cardiopulmonary bypass and the residual blood from the heart lung machine will be transfused unfiltered, which is at this moment routine practice.
In group I and II all the wound suction blood during the operation will be transferred to the cell saver instead of being wasted or returned to the heart lung machine as usual. In addition, the residual heart lung machine blood will be processed by the cell saver instead of being unprocessed transfused to the patient as usual.
Intervention type
Device
Phase
Drug names
Primary outcome measure
The number of allogenic blood products used.
Secondary outcome measures
1. Length of stay in the intensive care unit and in the hospital
2. Number of rethoracotomies (any re-exploration within 48 hours after the initial operation)
3. Myocardial infarction (new Q-wave on the electrocardiogram [ECG] and creatine kinase [CK] greater than 180 U/l with creatine kinase myocardial bands [CK-MB] greater than 10% of total)
4. Renal (serum creatinine greater than 1.5 baseline) and pulmonary dysfunction
5. Peri-operative infections
6. Costs of the interventions
7. Coagulation disorders
8. Markers of inflammation (leukocyte and granulocyte counts, interleukin-6, elastase, C-reactive protein, myeloperoxidase)
Overall trial start date
01/12/2004
Overall trial end date
01/06/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adult patients scheduled for cardiac surgery
2. Informed consent
The study is not blinded, because intraoperative cell saving cannot be concealed by the size and noise of the apparatus. Blockwise randomisation will be employed to avoid imbalance. Numbered, sealed randomisation envelopes will be used. Randomisation will be registered centrally. The randomisation code will not be revealed to any of the participating investigators.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
650
Participant exclusion criteria
1. Patients with known coagulation disorders except from the use of aspirin or low molecular weight heparin given at least 10 hours before surgery
2. Patients under 18 years
3. Patients presenting for emergency operations
Recruitment start date
01/12/2004
Recruitment end date
01/06/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Universitair Medisch Centrum Groningen
Groningen
9700 RB
Netherlands
Sponsor information
Organisation
University Medical Centre Groningen (UMCG) (The Netherlands)
Sponsor details
Department of General Practice
Hanzeplein 1
Groningen
9713 GZ
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Netherlands Organisation for Health Research and Development
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25440265
2019 results in: http://www.ncbi.nlm.nih.gov/pubmed/30610759