Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
12/11/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Dick J. van Rhenen

ORCID ID

Contact details

Sanquin Blood Bank South West Region
Wytemaweg 10
Rotterdam
3015 CN
Netherlands
+31 (0)10 463 0630
dick.van.rhenen@bloodrtd.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

TEMPLE study

Study hypothesis

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

Ethics approval received from the local medical ethics committee

Study design

Multicentre, randomised, single blind, active controlled, parallel group trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Myelodysplastic Syndrome (MDS)

Intervention

Red blood cell transfusion.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Fatigue.

Secondary outcome measures

1. Health Related Quality of Life (HRQoL)
2. Blood usage and the costs
3. Haemoglobin increase after transfusion
4. Heart beat, blood pressure, temperature, platelet count
5. Development of RBC alloantibodies
6. Mortality

Overall trial start date

10/02/2002

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

200

Participant 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

Recruitment start date

10/02/2002

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Sanquin Blood Bank South West Region
Rotterdam
3015 CN
Netherlands

Sponsor information

Organisation

Sanquin Blood Bank South West Region (The Netherlands)

Sponsor details

Wytemaweg 10
Rotterdam
3015 CN
Netherlands

Sponsor type

Research organisation

Website

http://www.sanquin.nl/sanquin-nl/sqn_home_nl.nsf

Funders

Funder type

Government

Funder name

The Netherlands Ministry of Health, Welfare and Sport (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institute of Public Health and Environmental Protection (RIVM) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Friends of the Blood Transfusion Foundation (Stichting Vrienden van de Bloedtransfusie) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Pilot study results in: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=12694248

Publication citations

  1. Pilot study results

    Jansen AJ, Essink-Bot ML, Beckers EA, Hop WC, Schipperus MR, Van Rhenen DJ, Quality of life measurement in patients with transfusion-dependent myelodysplastic syndromes., Br. J. Haematol., 2003, 121, 2, 270-274.

Additional files

Editorial Notes