Effects of transfusion of leucocyte-depleted erythrocytes in cardiac valve surgey on postoperative complications

ISRCTN ISRCTN68522192
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

Sanquin Blood Bank
Department of Research and Education
Plesmanlaan 1a
Leiden
2333 BZ
Netherlands

Phone +31 (0)71 568 5053
Email bilginyavuz@hotmail.com

Study information

Study designMulticentre, randomised, double blinded, active controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleEffects of transfusion of leucocyte-depleted erythrocytes in cardiac valve surgey on postoperative complications
Study objectivesTo 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) studiedHeart surgery
InterventionRandomisation 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 typeProcedure/Surgery
Primary outcome measure90-days mortality and causes of deaths.
Secondary outcome measures1. 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 date01/05/1999
Completion date01/05/2001

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants496
Total final enrolment496
Key inclusion criteriaPatients undergoing valve surgery (+/- Coronary Artery Bypass Grafting [CABG]).
Key exclusion criteria1. Patients under 18 years of age
2. Medical indications for leucocyte-depleted erythrocytes
3. Received blood transfusions within previous 3 months
Date of first enrolment01/05/1999
Date of final enrolment01/05/2001

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Sanquin Blood Bank
Leiden
2333 BZ
Netherlands

Sponsor information

Netherlands Heart Foundation (Nederlandse Hartstichting) (Netherlands)
Charity

P.O. Box 300
Den Haag
2501 CH
Netherlands

Phone +31 (0)70 315 5555
Email info@hartstichting.nl
Website http://www.hartstichting.nl/go/
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot 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.