mbilical cord blood transfusion for children with severe anaemia (Wazo Geni study)
- Conditions
- Severe anaemiaHaematological DisordersAnaemia
- Registration Number
- ISRCTN66687527
- Lead Sponsor
- iverpool School of Tropical Medicine (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Amended as of 16/02/2009:<br>1. Serious adverse events<br>2. Suspected unexpected serious adverse reactions<br>3. Adverse events<br><br>Initial information at time of registration:<br>1. Serious adverse events<br>2. Suspected unexpected serious adverse reactions<br><br>Monitored throughout in-patient stay with formal assessments at the following times:<br>1. Pre-transfusion<br>2. During transfusion <br>3. Two hours post transfusion<br>4. 24 hours post transfusion<br>5. At hospital discharge<br>6. 28 days post transfusion
- Secondary Outcome Measures
Name Time Method Rise in haemoglobin at 24 hours and 28 days.<br>