Umbilical cord blood transfusion for children with severe anaemia (Wazo Geni study)

An unmasked, single arm trial to assess harm, safety and efficacy of umbilical cord red blood cell transfusion for children with severe anaemia in a Kenyan hospital

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN66687527

Enrollment

Registered

2007-07-05

Start date

2007-06-25

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Severe anaemia Haematological Disorders Anaemia

Interventions

Amended as of 16/02/2009: Umbilical cord red blood cells from a maximum of two cord blood donations to provide a minimum quantity of haemoglobin equivalent to 20 ml/kg of adult-donated whole blood. Tr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Children aged 12 years or less, either sex 2. Children with severe anaemia for whom a blood transfusion is indicated (aged less than three months, Haemoglobin [Hb] less than or equal to 10 g/dL; aged greater than three months, Hb less than or equal to 4 g/dL)

Exclusion criteria

Exclusion criteria: 1. Coma (Blantyre Coma Scale less than or equal to 2) 2. Prostration (if unable to sit when well, inability to take enteral feeds; if able to sit when well, inability to sit unsupported) 3. Uncompensated shock 4. Compensated shock (capillary refill time greater than 3 seconds; temperature gradient) 5. Respiratory distress (deep breathing) 6. Neonatal hyperbilirubinaemia requiring exchange transfusion 7. Any other marker of clinical severity considered to preclude the child from recruitment into the study 8. Enrolment in another intervention trial 9. Children for whom informed consent to enter the study is not possible or not given

Design outcomes

Primary

Measure	Time frame
Amended as of 16/02/2009: 1. Serious adverse events 2. Suspected unexpected serious adverse reactions 3. Adverse events Initial information at time of registration: 1. Serious adverse events 2. Suspected unexpected serious adverse reactions Monitored throughout in-patient stay with formal assessments at the following times: 1. Pre-transfusion 2. During transfusion 3. Two hours post transfusion 4. 24 hours post transfusion 5. At hospital discharge 6. 28 days post transfusion	—

Measure

Time frame

Amended as of 16/02/2009: 1. Serious adverse events 2. Suspected unexpected serious adverse reactions 3. Adverse events Initial information at time of registration: 1. Serious adverse events 2. Suspected unexpected serious adverse reactions Monitored throughout in-patient stay with formal assessments at the following times: 1. Pre-transfusion 2. During transfusion 3. Two hours post transfusion 4. 24 hours post transfusion 5. At hospital discharge 6. 28 days post transfusion

—

Secondary

Measure	Time frame
Rise in haemoglobin at 24 hours and 28 days.	—

Countries

Kenya

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 18, 2026