Temple study.

Transfusion Effects of Myelodysplastic Patients: Limiting Exposure.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24147

Enrollment

200

Registered

2005-09-10

Start date

2002-02-10

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MDS patients

Interventions

Red blood cell transfusion.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosis myelodysplastic syndrome (primary or secondary) based on cytopenia in at least 1 cell line + dysplasia in 2 cell lines (and no other cause (especially deficiencies)) and a pathologic anatomic diagnosis after bone marrow punction; 2. Refractory anaemia (RA): blood: ¡Ü 1% blasts, ¡Ü 1 x 109 monocytes; bone marrow: 15% of the erythroid cells; 4. Refractory anaemia with excess blasts (RAEB): blood: 1 x 109/l monocytes, <5% blasts; bone marrow: blasts < 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).

Exclusion criteria

Exclusion criteria: 1. Candidate for bone marrow- or organ transplantation; 2. Medication: growth factors (GM-CSF), or 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): blood: ¡Ý 5% blasts or Auer rods; bone marrow: or blasts > 20 - < 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 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.

Design outcomes

Primary

Measure	Time frame
Fatigue.	—

Secondary

Measure	Time frame
1. Health related Quality of Life; 2. Blood usage and the costs; 3. Haemoglobin increase after transfusion; 4. Hart beat, blood pressure, temperature, platelet count; 5. Development of RBC alloantibodies; 6. Mortality.	—

Contacts

Public ContactDick J. Rhenen, van

Sanquin Blood Bank South West Region, Wytemaweg 10

dick.van.rhenen@bloodrtd.nl+31 (0)10 4630630

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)