Transfusion Effects of Myelodysplastic Patients: Limiting Exposure
| ISRCTN | ISRCTN43616311 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43616311 |
| Protocol serial number | N/A |
| Sponsor | Sanquin Blood Bank South West Region (The Netherlands) |
| Funders | The Netherlands Ministry of Health, Welfare and Sport (The Netherlands), National Institute of Public Health and Environmental Protection (RIVM) (The Netherlands), Friends of the Blood Transfusion Foundation (Stichting Vrienden van de Bloedtransfusie) (The Netherlands) |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 27/09/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Dick J. van Rhenen
Scientific
Scientific
Sanquin Blood Bank South West Region
Wytemaweg 10
Rotterdam
3015 CN
Netherlands
| Phone | +31 (0)10 463 0630 |
|---|---|
| dick.van.rhenen@bloodrtd.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised, single blind, active controlled, parallel group trial. |
| Secondary study design | Randomised controlled trial |
| Scientific title | Transfusion Effects of Myelodysplastic Patients: Limiting Exposure |
| Study acronym | TEMPLE study |
| Study objectives | 1. There is no difference in Health Related Quality of Life (HRQoL) using a Haemoglobin (Hb) transfusion trigger of 7.2 g/dl compared to Hb transfusion trigger of 9.6 g/dl 2. A Hb transfusion trigger of 7.2 g/dl leads to a diminished use of Red Blood Cell (RBC) transfused compared to a Hb transfusion trigger of 9.6 g/dl 3. A Hb transfusion trigger of 7.2 g/dl leads to a decrease in the development of RBC allo-antibodies |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Myelodysplastic Syndrome (MDS) |
| Intervention | Red blood cell transfusion. |
| Intervention type | Other |
| Primary outcome measure(s) |
Fatigue. |
| Key secondary outcome measure(s) |
1. Health Related Quality of Life (HRQoL) |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 200 |
| Key inclusion criteria | 1. Diagnosis myelodysplastic syndrome (primary or secondary) based on cytopenia in at least 1 cell line and dysplasia in 2 cell lines (and no other cause [especially deficiencies]) and a pathologic anatomic diagnosis after bone marrow punction 2. Refractory Anaemia (RA): 2.1. Blood: less than or equal to 1% blasts, less than or equal to 1 x 10^9 monocytes 2.2. Bone marrow: less than 5% blasts, ringed sideroblasts less than or equal to 15% of the erythroid cells 3. Refractory Anaemia with Ringed Sideroblasts (RARS): 3.1. Blood: less than or equal to 1% blasts, less than or equal to 1 x 10^9 monocytes 3.2. Bone marrow: less than 5% blasts, ringed sideroblasts greater than 15% of the erythroid cells 4. Refractory Anaemia with Excess Blasts (RAEB): 4.1. Blood: less than 5% blasts, less than or equal to 1 x 10^9 monocytes 4.2. Bone marrow: blasts greater than or equal to 5% to less than or equal to 20% 5. Chronic Myelomonocytic Leukaemia (CMML): 5.1. Blood: greater than 1 x 10^9/l monocytes, less than 5% blasts 5.2. Bone marrow: blasts less than 20%, increase of the monocytic component 6. Erythrocyte transfusion need 7. Working knowledge of the national language 8. Written consent for participating this study (informed consent) |
| Key exclusion criteria | 1. Candidate for bone marrow or organ transplantation 2. Medication: growth factors (Granulocyte Monocyte Colony Stimulating Factor [GM-CSF]), or Erythropoietin (EPO) 3. Patients who will receive an intensive chemotherapeutic treatment with a cytopenia, expected longer than 2 weeks 4. Refractory anaemia with excess blasts in transformation (RAEB-t): 4.1. Blood: 5% blasts or Auer rods 4.2. Bone marrow: or blasts greater than 20% to less than 30% or Auer rods 5. Pregnancy at the moment of inclusion 6. Patients with congenital severe haemolytic anaemia, like thalassemia or sickle cell anaemia 7. Patients with Acquired Immune Deficiency Syndrome (AIDS) or a severe congenital or acquired (e.g., iatrogenic) immunological disorder 8. Severe active infections at the moment of inclusion 9. Severe cardiac, pulmonal, neurological, metabolic or psychiatric disease at the moment of inclusion |
| Date of first enrolment | 10/02/2002 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Sanquin Blood Bank South West Region
Rotterdam
3015 CN
Netherlands
3015 CN
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2003 | Yes | No |
Editorial Notes
27/09/2017: internal review.
