Condition category
Surgery
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
12/11/2007
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 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

http://www.hartstichting.nl/go/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes