No registrations found.
ID
Source
Health condition
Patiƫnts with a chronic need for bloodtransfusion due to e.g. myelodysplatic syndrome, myelofibrosis or myeloproliferative conditions.
Sponsors and support
Postbus 50.000
7500 KA Enschede
tel. 053 487 2000
The Netherlands
Intervention
Outcome measures
Primary outcome
Quality of life assesed with the EORTC QLQ C-30 questionnaire.
Secondary outcome
1. Number of transfusion units;
2. Transfusionfrequency;
3. Average Hb concentration before transfusion;
4. Number and duration of hospital visits.
Background 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.
Study objective
A constant Hb concentration will improve the quality of life of patiƫnts with a chronic need for bloodtransfusions.
Study design
1x/3 months questionnaire concerning quality of life.
Intervention
Transfusion with either:
1. 1 erythrocyte concentrate;
2. 2 erythrocyte concentrate.
Postbus 50.000
A.W. Duyts
Enschede 7500 KA
The Netherlands
+31 (0)53 4872000
a.duyts@MST.nl
Postbus 50.000
A.W. Duyts
Enschede 7500 KA
The Netherlands
+31 (0)53 4872000
a.duyts@MST.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL2293 |
NTR-old | NTR2684 |
Other | METC Medisch Spectrum Twente Enschede : P10-36 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |