Effects of transfusion of leucocyte-depleted erythrocytes in cardiac valve surgey on postoperative complications
ISRCTN | ISRCTN68522192 |
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DOI | https://doi.org/10.1186/ISRCTN68522192 |
Secondary identifying numbers | N/A |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 14/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Y.M. Bilgin
Scientific
Scientific
Sanquin Blood Bank
Department of Research and Education
Plesmanlaan 1a
Leiden
2333 BZ
Netherlands
Phone | +31 (0)71 568 5053 |
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bilginyavuz@hotmail.com |
Study information
Study design | Multicentre, randomised, double blinded, active controlled, parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | Effects of transfusion of leucocyte-depleted erythrocytes in cardiac valve surgey on postoperative complications |
Study objectives | To investigate the role and mechanisms of leukocytes in allogeneic erythrocyte concentrates on postoperative complications, as Multiple Organ Dysfunction Syndrome (MODS), infections and death. |
Ethics approval(s) | Ethics approval received from the local medical ethics committee |
Health condition(s) or problem(s) studied | Heart surgery |
Intervention | Randomisation to receive buffy-coat-depleted (PC) or leukocyte-depleted transfusions when necessary. Pre-operative, at arrival at Intensive Care Unit (ICU) and day 1 postoperatively at ICU blood samples were obtained. |
Intervention type | Procedure/Surgery |
Primary outcome measure | 90-days mortality and causes of deaths. |
Secondary outcome measures | 1. In-hospital mortality 2. 30- and 60-days mortality 3. Onset and type of postoperative infections 4. Onset and type of MODS 5. ICU-stay, hospital-stay and long-term survival 6. Pro-and anti-inflammatory cytokine profile, complement system activation and inflammatory mediators 7. Cost-effective-analysis for the primary outcome |
Overall study start date | 01/05/1999 |
Completion date | 01/05/2001 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 496 |
Total final enrolment | 496 |
Key inclusion criteria | Patients undergoing valve surgery (+/- Coronary Artery Bypass Grafting [CABG]). |
Key exclusion criteria | 1. Patients under 18 years of age 2. Medical indications for leucocyte-depleted erythrocytes 3. Received blood transfusions within previous 3 months |
Date of first enrolment | 01/05/1999 |
Date of final enrolment | 01/05/2001 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Sanquin Blood Bank
Leiden
2333 BZ
Netherlands
2333 BZ
Netherlands
Sponsor information
Netherlands Heart Foundation (Nederlandse Hartstichting) (Netherlands)
Charity
Charity
P.O. Box 300
Den Haag
2501 CH
Netherlands
Phone | +31 (0)70 315 5555 |
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info@hartstichting.nl | |
Website | http://www.hartstichting.nl/go/ |
https://ror.org/05nxhgm70 |
Funders
Funder type
Charity
Netherlands Heart Foundation (The Netherlands) (grant ref: 98.183)
No information available
Results and Publications
Intention to publish date | |
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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 | Not provided at time of registration |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | 08/06/2004 | Yes | No | ||
Other publications | 01/06/2005 | Yes | No |
Editorial Notes
14/11/2022: Total final enrolment added.