A constant Hb concentration will improve the quality of life of patiënts with a chronic need for bloodtransfusions.
ID
Bron
Aandoening
Patiënts with a chronic need for bloodtransfusion due to e.g. myelodysplatic syndrome, myelofibrosis or myeloproliferative conditions.
Ondersteuning
Postbus 50.000
7500 KA Enschede
tel. 053 487 2000
The Netherlands
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Quality of life assesed with the EORTC QLQ C-30 questionnaire.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
A constant Hb concentration will improve the quality of life of patiënts with a chronic need for bloodtransfusions.
Onderzoeksopzet
1x/3 months questionnaire concerning quality of life.
Onderzoeksproduct en/of interventie
Transfusion with either:
1. 1 erythrocyte concentrate;
2. 2 erythrocyte concentrate.
Algemeen / deelnemers
Postbus 50.000
A.W. Duyts
Enschede 7500 KA
The Netherlands
+31 (0)53 4872000
a.duyts@MST.nl
Wetenschappers
Postbus 50.000
A.W. Duyts
Enschede 7500 KA
The Netherlands
+31 (0)53 4872000
a.duyts@MST.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Need for chronic transfusion;
2. 18-85 years;
3. Patient is fully competent;
4. Written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Chemotherapy;
2. Extra-medullary hematopoiesis;
3. Language barrier.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL2293 |
NTR-old | NTR2684 |
Ander register | METC Medisch Spectrum Twente Enschede : P10-36 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |