Condition category
Surgery
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
23/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr L.M.G. van de Watering

ORCID ID

Contact details

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

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

http://www.lumc.nl/

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

  1. 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.

  2. 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.

  3. Fluit CR, Kunst VA, Drenthe-Schonk AM, Incidence of red cell antibodies after multiple blood transfusion., Transfusion, 30, 6, 532-535.

Additional files

Editorial Notes