Leiden-Alloimmunisation-Likelihood (LAL) trial: alloimmunisation after pre-storage filtered, post-storage filtered and buffy-coat-depleted blood transfusion in cardiac surgery patients

ISRCTN	ISRCTN45666086
DOI	https://doi.org/10.1186/ISRCTN45666086
Protocol serial number	n/a
Sponsor	Leiden University Medical Centre (LUMC) (Netherlands)
Funders	Red Cross Blood Bank Leidsenhage (The Netherlands), NPBI International B.V. (The Netherlands)

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 23/10/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr L.M.G. van de Watering
Scientific

Sanquin Blood Bank
Southwest region
Plesmanlaan 1a
Leiden
2333 BZ
Netherlands

Study information

Primary study design	Interventional
Study design	Randomised, double blinded, active controlled, parallel group trial.
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	LAL trial
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	15/08/1994

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	944
Key inclusion criteria	Patients planned for open heart surgery: Coronary Artery Bypass Graft (CABG), heart valve surgery or the combination of both.
Key exclusion criteria	1. Aged less than 18 years 2. Transfusions within last 6 months 3. Pre-existing medical indication for filtered blood products
Date of first enrolment	01/03/1992
Date of final enrolment	15/08/1994

Locations

Countries of recruitment

Netherlands

Study participating centre

Sanquin Blood Bank

Leiden
2333 BZ
Netherlands

Results and Publications

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

Study outputs

Output type	Date created	Peer reviewed?	Patient-facing?
Other publications	01/07/1990	Yes	No
Other publications	17/02/1998	Yes	No
Other publications	01/01/2003	Yes	No