Condition category
Injury, Occupational Diseases, Poisoning
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
11/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.umcg.nl/azg/nl/

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

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25440265

Publication citations

Additional files

Editorial Notes