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 |
| Secondary identifying numbers | NTR244 |
- 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
Scientific
Universitair Medisch Centrum Groningen
Department of Anesthesiology
Hanzeplein 1
P.O. Box 30001
Groningen
9700 RB
Netherlands
| Phone | +31 (0)50 3612341 |
|---|---|
| j.a.m.hagenaars@anest.umcg.nl |
Study information
| Study design | Multicentre randomised unblinded active-controlled parallel-group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 01/12/2004 |
| Completion date | 01/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
9700 RB
Netherlands
Sponsor information
University Medical Centre Groningen (UMCG) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of General Practice
Hanzeplein 1
Groningen
9713 GZ
Netherlands
| Website | http://www.umcg.nl/azg/nl/ |
|---|---|
"ROR" |
https://ror.org/03cv38k47 |
Funders
Funder type
Research organisation
Netherlands Organisation for Health Research and Development
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
