|- candidate number||8874|
|- NTR Number||NTR2684|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-jan-2011|
|- Secondary IDs||P10-36 METC Medisch Spectrum Twente Enschede|
|- Public Title||Transfusion as supportive care for the improvement of the quality of life.|
|- Scientific Title||Transfusion as supportive care.|
|- hypothesis||A constant Hb concentration will improve the quality of life of patiŽnts with a chronic need for bloodtransfusions.|
|- Healt Condition(s) or Problem(s) studied||Blood transfusions, Myelodysplastic syndrome (MDS), Chronic, Myelofibrosis, Myeloproliferative conditions|
|- Inclusion criteria||1. Need for chronic transfusion;|
2. 18-85 years;
3. Patient is fully competent;
4. Written informed consent.
|- Exclusion criteria||1. Chemotherapy;|
2. Extra-medullary hematopoiesis;
3. Language barrier.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2011|
|- planned closingdate||31-dec-2012|
|- Target number of participants||100|
|- Interventions||Transfusion with either:|
1. 1 erythrocyte concentrate;
2. 2 erythrocyte concentrate.
|- Primary outcome||Quality of life assesed with the EORTC QLQ C-30 questionnaire.|
|- Secondary outcome||1. Number of transfusion units;|
3. Average Hb concentration before transfusion;
4. Number and duration of hospital visits.
|- Timepoints||1x/3 months questionnaire concerning quality of life.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| A.W. Duyts|
|- CONTACT for SCIENTIFIC QUERIES||Mw. Dr. J. Slomp|
|- Sponsor/Initiator ||Medisch Spectrum Twente|
(Source(s) of Monetary or Material Support)
|Tekke Huizinga Fonds|
|- Brief summary||Improvement or maintaining quality of life is an important goal for patients that receive supportive care as their sole treatment. Blood transfusion can be considered as supportive care for patients with chronic anemia. Patients receive a blood transfusion if their Hb concentration is below 5.0 mmol/l. Under the current protocol, patients receive 2 units of packed cells per transfusion. Patients indicate that they feel better, however there are no objective data available on the quality of life, the optimal transfusion trigger and the quantity of packed cells needed to improve the patients well being. Due to the administration of 2 units of packed cell at every blood transfusion, large fluctuations in Hb concentration occur. This might increase the need for blood transfusions and affect the average quality of life.|
Our hypothesis is that patients will feel better is their Hb concentration is maintained at a relative constant level and that the transfusion trigger can be lowered on asymptomatic patients.
Patients receiving blood transfusion as supportive care will be approached for this study. Upon enrollment, patients will be randomized in two groups:
1. Standard group undergoing the current protocol of 2 units of packed cells/transfusion;
2. Intervention group will receive only 1 unit of packed cells/transfusion.
The quality of life will repeatedly be assessed by a questionnaire, secondary measurements consist of average Hb concentration, frequency of transfusions en visits to the hospital etc.
Our patients will be recruited initially from Medisch Spectrum Twente, Enschede, the Netherlands.
|- Main changes (audit trail)|
|- RECORD||5-jan-2011 - 21-jan-2011|