Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
n/a
Study information
Scientific title
Acronym
LAL trial
Study hypothesis
The use of by filtration-leukocyte reduced blood transfusions in patients undergoing cardiac surgery, will result in lower alloimmunisation frequencies compared to using buffy-coat depleted blood transfusions. This has previously been shown in frequently transfused patients that received transfusions over a longer period of time, and is now investigated in patients receiving several units of blood around a single event, cardiac surgery. Also being investigated in this study is whether post-storage filtration is as effective as pre-storage filtration.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
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
Blood transfusions in cardiac surgery
Intervention
Use of by filtration leukocyte reduced blood transfusions versus use of buffy-coat depleted blood transfusions (=1990's standard in NL).
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Anti-Human Leukocyte Antigen (HLA) antibody formation (tested by LCT) and anti-erythrocyte antibody formation (tested in 3 cell panel, with PEG). Samples for analyses are collected before surgery, on day 7 post-surgery, 3 - 10 weeks post-surgery and 20 - 30 weeks post-surgery.
Secondary outcome measures
1. Post-operative infections
2. Hospital stay
3. Intensive Care Unit (ICU)-stay
4. Mortality
5. Costs-effect-analyses
6. In combination with other Randomised Controlled Trials (RCTs), that have randomised between these same two blood products: long term effects on the incidence of autoimmune diseases and malignancies
Overall trial start date
01/03/1992
Overall trial end date
15/08/1994
Reason abandoned
Eligibility
Participant inclusion criteria
Patients planned for open heart surgery: Coronary Artery Bypass Graft (CABG), heart valve surgery or the combination of both.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
944
Participant exclusion criteria
1. Aged less than 18 years
2. Transfusions within last 6 months
3. Pre-existing medical indication for filtered blood products
Recruitment start date
01/03/1992
Recruitment end date
15/08/1994
Locations
Countries of recruitment
Netherlands
Trial participating centre
Sanquin Blood Bank
Leiden
2333 BZ
Netherlands
Sponsor information
Organisation
Leiden University Medical Centre (LUMC) (Netherlands)
Sponsor details
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Red Cross Blood Bank Leidsenhage (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NPBI International B.V. (The Netherlands)
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=9494026
2. http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=12542735
3. http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=2378025
Publication citations
-
van de Watering LM, Hermans J, Houbiers JG, van den Broek PJ, Bouter H, Boer F, Harvey MS, Huysmans HA, Brand A, Beneficial effects of leukocyte depletion of transfused blood on postoperative complications in patients undergoing cardiac surgery: a randomized clinical trial., Circulation, 1998, 97, 6, 562-568.
-
Postma MJ, van de Watering LM, de Vries R, Versmoren D, van Hulst M, Tobi H, van der Poel CL, Brand A, Cost-effectiveness of leucocyte depletion of red-cell transfusions for patients undergoing cardiac surgery., Vox Sang., 2003, 84, 1, 65-67.
-
Fluit CR, Kunst VA, Drenthe-Schonk AM, Incidence of red cell antibodies after multiple blood transfusion., Transfusion, 30, 6, 532-535.