Contact information
Type
Scientific
Primary contact
Dr Y.M. Bilgin
ORCID ID
Contact details
Sanquin Blood Bank
Department of Research and Education
Plesmanlaan 1a
Leiden
2333 BZ
Netherlands
+31 (0)71 568 5053
bilginyavuz@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics approval received from the local medical ethics committee
Study design
Multicentre, randomised, double blinded, 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
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/05/1999
Overall trial end date
01/05/2001
Reason abandoned
Eligibility
Participant inclusion criteria
Patients undergoing valve surgery (+/- Coronary Artery Bypass Grafting [CABG]).
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
496
Participant exclusion criteria
1. Patients under 18 years of age
2. Medical indications for leucocyte-depleted erythrocytes
3. Received blood transfusions within previous 3 months
Recruitment start date
01/05/1999
Recruitment end date
01/05/2001
Locations
Countries of recruitment
Netherlands
Trial participating centre
Sanquin Blood Bank
Leiden
2333 BZ
Netherlands
Sponsor information
Organisation
Netherlands Heart Foundation (Nederlandse Hartstichting) (Netherlands)
Sponsor details
P.O. Box 300
Den Haag
2501 CH
Netherlands
+31 (0)70 315 5555
info@hartstichting.nl
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Netherlands Heart Foundation (The Netherlands) (grant ref: 98.183)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Results in:
1. http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=15148271
2. http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=15943705
Publication citations
-
Bilgin YM, van de Watering LM, Eijsman L, Versteegh MI, Brand R, van Oers MH, Brand A, Double-blind, randomized controlled trial on the effect of leukocyte-depleted erythrocyte transfusions in cardiac valve surgery., Circulation, 2004, 109, 22, 2755-2760, doi: 10.1161/01.CIR.0000130162.11925.21.
-
van Hulst M, Bilgin YM, van de Watering LM, de Vries R, van Oers MH, Brand A, Postma MJ, Cost-effectiveness of leucocyte-depleted erythrocyte transfusion in cardiac valve surgery., Transfus Med, 2005, 15, 3, 209-217, doi: 10.1111/j.1365-3148.2005.00573.x.