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Leiden-Alloimmunization-Likelihood (LAL)trial.

Alloimmunization after pre-storage filtered, post-storage filtered and buffy-coat-depleted blood transfusion in cardiac surgery patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20534
Enrollment
944
Registered
2005-09-07
Start date
1992-03-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open heart surgery: CABG, heart valve surgery and the combination of both.

Interventions

Use of by filtration leukocyte reduced blood transfusions vs use of buffy-coat depleted blood transfusions (=1990's standard in NL).

Sponsors

Leiden University Medical Center; Red Cross Blood Bank Leidsenhage, Leiden
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients planned for open heart surgery: CABG, heart valve surgery or the combination of both.

Exclusion criteria

Exclusion criteria: 1. Age < 18 year; 2. Transfusions within last 6 months; 3. Pre-existing medical indication for filtered blood products.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. 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.

Contacts

Public ContactL.M.G. Watering, van de

Sanquin Blood Bank, Southwest region, Plesmanlaan 1a

+31 (0)71 5685053

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)