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

ISRCTN	ISRCTN68522192
DOI	https://doi.org/10.1186/ISRCTN68522192
Protocol serial number	N/A
Sponsor	Netherlands Heart Foundation (Nederlandse Hartstichting) (Netherlands)
Funder	Netherlands Heart Foundation (The Netherlands) (grant ref: 98.183)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Multicentre, randomised, double blinded, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
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(s)	90-days mortality and causes of deaths.
Key secondary outcome measure(s)	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
Completion date	01/05/2001

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Sanquin Blood Bank

Leiden
2333 BZ
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

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

14/11/2022: Total final enrolment added.