|- candidate number||2954|
|- NTR Number||NTR1164|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-dec-2007|
|- Secondary IDs||Sanquin: PPOC 06-017 CME-ZWH: 07-099 ABR: 17890 Sanquin, CME-ZWH, CCMO|
|- Public Title||Match study|
|- Scientific Title||Preventive extended red blood cell matching: when and how?|
|- ACRONYM||Match study|
|- hypothesis||Investigate the benefits and costs of extended RBC antigen matching to prevent alloimmunization.|
|- Healt Condition(s) or Problem(s) studied||Red blood cell antibodies|
|- Inclusion criteria||The general transfusion population >18 years requiring an elective RBC transfusion.|
|- Exclusion criteria||1. Patients younger than 18 years;|
2. Patients with an a priori indication for matched transfusions;
3. Patients with a positive direct antiglobulin test;
4. Patients who, based on the local pre-operative blood-ordering list, require more than 4 units during surgery;
5. Incapacitated subjects or patients who cannot understand the information.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2008|
|- planned closingdate||1-aug-2010|
|- Target number of participants||1120|
|- Interventions||Patients are randomly assigned to receive standard ABO-D matched or extended (C, E, c, e, K, Fya, Jka and S) matched RBC transfusions.|
|- Primary outcome||Incidence of alloimmunization in transfusion patients through preventive donor matching for the clinically relevant blood cell antigens compared to standard matching in patients stratified for high risk and random risk for alloimmunization.|
|- Secondary outcome||Cost-analysis for current serologic screen and match strategy compared to preventive matching strategy in the two strata of patients.|
Health benefits: investigate transfusion and/or other medical treatment delay in case of RBC alloimmunization.
Clinical and genetic factors associated with alloimmunization.
|- Timepoints||Follow-up after 7-10 days, 1 month and 4-6 months following transfusion.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| H. Schonewille|
|- CONTACT for SCIENTIFIC QUERIES|| A. Brand|
|- Sponsor/Initiator ||Sanquin Blood Bank South West Region|
(Source(s) of Monetary or Material Support)
|- Publications||To be expected.|
|- Brief summary||Rationale: |
Preventive extended matching for red blood cell (RBC) transfusions is currently only applied for high risk hematological patients and females of (pre) child-bearing age. RBC transfusions elicit antibodies in 2-9% after a first transfusion episode, but antibody responders have a high (>20%) risk for additional antibody formation upon subsequent transfusions. Prior to availability of new technology enabling large scale extended donor RBC antigen genotyping we propose to evaluate for which patients extensive matching is efficient and may be cost-effective.
This study investigates the benefits and costs of extended RBC antigen matching to prevent alloimmunization. Preventive RBC matching will be evaluated in two transfusion populations with different (high and random) risks for alloimmunization. This will identify the population for which preventive matching will be most efficient as compared to a random population and reveal the optimal and cheapest application for an expected new intervention such as large scale genotyping of donors.
Randomized controlled double-blinded multicenter intervention study.
Patients with a first or subsequent transfusion event, stratified for patients with alloantibodies after a previous transfusion.
Patients are randomly assigned to receive standard ABO-D matched or extended (C, E, c, e, K, Fya, Jka and S) matched RBC transfusions.
Main study parameters/endpoints:
1. Decrease in alloimmunization in transfusion patients through preventive donor matching for the clinically relevant blood cell antigens (C, E, c, e, K, Fya, Jka and S), responsible for more than 80% of immunization cases, in patients stratified for high and random alloimmunization risk;
2. Cost-analysis for current serologic screen and match strategy compared to preventive matching strategy in the 2 strata of patients.
|- Main changes (audit trail)|
|- RECORD||18-dec-2007 - 9-apr-2008|