The clinical effects of leukocyte removal filters, cell savers and their combination on blood transfusion and organ damage during cardiac surgery

ISRCTN	ISRCTN58333401
DOI	https://doi.org/10.1186/ISRCTN58333401
Protocol serial number	NTR244
Sponsor	University Medical Centre Groningen (UMCG) (The Netherlands)
Funder	Netherlands Organisation for Health Research and Development

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 07/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr J.A.M. Hagenaars
Scientific

Universitair Medisch Centrum Groningen
Department of Anesthesiology
Hanzeplein 1
P.O. Box 30001
Groningen
9700 RB
Netherlands

Phone	+31 (0)50 3612341
Email	j.a.m.hagenaars@anest.umcg.nl

Study information

Primary study design	Interventional
Study design	Multicentre randomised unblinded active-controlled parallel-group trial
Secondary study design	Randomised controlled trial
Scientific title	The clinical effects of leukocyte removal filters, cell savers and their combination on blood transfusion and organ damage during cardiac surgery
Study acronym	filterstudie
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)
Primary outcome measure(s)	The number of allogenic blood products used.
Key secondary outcome measure(s)	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)
Completion date	01/06/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	650
Key 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.
Key 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
Date of first enrolment	01/12/2004
Date of final enrolment	01/06/2005

Locations

Countries of recruitment

Netherlands

Study participating centre

Universitair Medisch Centrum Groningen

Groningen
9700 RB
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2015		Yes	No
Results article	results	01/03/2019		Yes	No

Editorial Notes

07/01/2019: Publication reference added.