|- candidate number||1445|
|- NTR Number||NTR259|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||7-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||Leiden-Alloimmunization-Likelihood (LAL)trial.|
|- Scientific Title||Alloimmunization after pre-storage filtered, post-storage filtered and buffy-coat-depleted blood transfusion in cardiac surgery patients.|
|- ACRONYM||L A L - trial|
|- hypothesis||The 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) studied||Coronary Artery Bypass Grafting (CABG), Heart diseases, Heart surgery|
|- Inclusion criteria||Patients planned for open heart surgery: |
CABG, heart valve surgery or the combination of both.
|- Exclusion criteria||1. Age < 18 year;|
2. Transfusions within last 6 months;
3. Pre-existing medical indication for filtered blood products.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-1992|
|- planned closingdate||15-aug-1994|
|- Target number of participants||944|
|- Interventions||Use of by filtration leukocyte reduced blood transfusions vs use of buffy-coat depleted blood transfusions (=1990's standard in NL).|
|- Primary outcome||Anti-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||1. Post-operative infections;|
2. Hospital stay;
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.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MD. PhD. L.M.G. Watering, van de|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. L.M.G. Watering, van de|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|Red Cross Blood Bank Leidsenhage, NPBI bv, Emmer-Compascuum|
|- Publications||Circulation 1998; 97; 562-568|
Vox Sang. 2003; 84; 65-67
Transfusion 2003; 43; 765-771
|- Brief summary||Primary outcome and most secundary outcomes are published. |
Follow-up on long-term effects (decades) is still running.
|- Main changes (audit trail)|
|- RECORD||7-sep-2005 - 15-mei-2008|