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Leiden-Alloimmunization-Likelihood (LAL)trial.


- candidate number1445
- NTR NumberNTR259
- ISRCTNISRCTN45666086
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR7-sep-2005
- Secondary IDsN/A 
- Public TitleLeiden-Alloimmunization-Likelihood (LAL)trial.
- Scientific TitleAlloimmunization after pre-storage filtered, post-storage filtered and buffy-coat-depleted blood transfusion in cardiac surgery patients.
- ACRONYML A L - trial
- hypothesisThe use of by filtration-leukocyte reduced blood transfusions in patients undergoing cardiac surgery, will result in lower alloimmunization 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.


Second hypothesis: If post-storage filtration is as effective as pre-storage filtration is also to being investigated in this study.
- Healt Condition(s) or Problem(s) studiedCoronary Artery Bypass Grafting (CABG), Heart diseases, Heart surgery
- Inclusion criteriaPatients planned for open heart surgery:
CABG, heart valve surgery or the combination of both.
- Exclusion criteria1. Age < 18 year;
2. Transfusions within last 6 months;
3. Pre-existing medical indication for filtered blood products.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-1992
- planned closingdate15-aug-1994
- Target number of participants944
- InterventionsUse of by filtration leukocyte reduced blood transfusions vs use of buffy-coat depleted blood transfusions (=1990's standard in NL).
- Primary outcomeAnti-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 outcome1. Post-operative infections;
2. Hospital stay;
3. ICU-stay;
4. Mortality;
5. Costs-effect-analyses.


In combination with other RCTs, that have randomized between these same two blood products: Long term effects on the incidence of autoimmune diseases and malignancies.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD. PhD. L.M.G. Watering, van de
- CONTACT for SCIENTIFIC QUERIESMD. PhD. L.M.G. Watering, van de
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Red Cross Blood Bank Leidsenhage, NPBI bv, Emmer-Compascuum
- PublicationsCirculation 1998; 97; 562-568
Vox Sang. 2003; 84; 65-67
Transfusion 2003; 43; 765-771
- Brief summaryPrimary outcome and most secundary outcomes are published.
Follow-up on long-term effects (decades) is still running.
- Main changes (audit trail)
- RECORD7-sep-2005 - 15-mei-2008


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