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 |
| Secondary identifying numbers | n/a |
- 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
Scientific
Sanquin Blood Bank
Southwest region
Plesmanlaan 1a
Leiden
2333 BZ
Netherlands
Study information
| Study design | Randomised, double blinded, active controlled, parallel group trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/03/1992 |
| Completion date | 15/08/1994 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
2333 BZ
Netherlands
Sponsor information
Leiden University Medical Centre (LUMC) (Netherlands)
University/education
University/education
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Website | http://www.lumc.nl/ |
|---|---|
"ROR" |
https://ror.org/027bh9e22 |
Funders
Funder type
Industry
Red Cross Blood Bank Leidsenhage (The Netherlands)
No information available
NPBI International B.V. (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | 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 |
