Umbilical cord blood transfusion for children with severe anaemia (Wazo Geni study)
| ISRCTN | ISRCTN66687527 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66687527 |
| Secondary identifying numbers | SSC 1215 |
- Submission date
- 01/07/2007
- Registration date
- 05/07/2007
- Last edited
- 22/12/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Oliver Hassall
Scientific
Scientific
KEMRI/Wellcome Trust Research Laboratories
PO Box 230
Kilifi
80108
Kenya
| ohassall@kilifi.kemri-wellcome.org |
Study information
| Study design | Phase 1b, open-label, non-randomised, non-controlled, single arm trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | 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 |
| Study objectives | Please note that as of 16/02/2009 this record was updated to include an amendment of the protocol from packed cord red blood cell transfusion to umbilical cord blood transfusion. All updates can be found in the relevant field under the above update date. The initial title (one title only) at the time of registration was: 'The safety and efficacy of packed cord red blood cell transfusion in children with severe anaemia in a Kenyan hospital'. Please also note that the anticipated end date has also changed; the initial end date at the time of registration was 31/03/2008. Current hypothesis as of 16/02/2009: Transfusion of umbilical cord red blood cells is safe and efficacious in the management of children with severe anaemia requiring blood transfusion in a Kenyan hospital. Initial information at time of registration: Transfusion of packed cord red blood cells is safe and efficacious in the management of children with severe anaemia requiring blood transfusion in a Kenyan hospital. |
| Ethics approval(s) | Approval received from: 1. KEMRI/National Ethics Committee on the 6th June 2007 (ref: SSC 1215) 2. Liverpool School of Tropical Medicine Research Ethics Committee on the 18th April 2007 (ref: 07.15) |
| Health condition(s) or problem(s) studied | Severe anaemia |
| Intervention | 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. Transfusions will be over 3 - 4 hours, with or without frusemide according to current international guidelines. There will be one transfusion episode per child. If further transfusions are required the child will receive standard management. Follow-up is for 28 days. Initial information at time of registration: A volume of packed cord blood cells from up to two cord blood units to be transfused to provide a minimum quantity of haemoglobin equivalent to 20 ml/kg of adult-donated whole blood. Transfusions will be over 3 - 4 hours, with or without frusemide according to current international guidelines. There will be one transfusion episode per child. If further transfusions are required the child will receive standard management. Follow-up is for 28 days. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase I/II |
| Drug / device / biological / vaccine name(s) | Umbilical cord blood transfusion |
| Primary outcome measure | 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 outcome measures | Rise in haemoglobin at 24 hours and 28 days. |
| Overall study start date | 25/06/2007 |
| Completion date | 17/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 80 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 25/06/2007 |
| Date of final enrolment | 17/06/2008 |
Locations
Countries of recruitment
- Kenya
Study participating centre
KEMRI/Wellcome Trust Research Laboratories
Kilifi
80108
Kenya
80108
Kenya
Sponsor information
Liverpool School of Tropical Medicine (UK)
University/education
University/education
c/o Professor Janet Hemingway
Pembroke Place
Liverpool
L3 5QA
England
United Kingdom
| Phone | +44 (0)151 705 3370 |
|---|---|
| hemingway@liverpool.ac.uk | |
| Website | http://www.liv.ac.uk/lstm/ |
"ROR" |
https://ror.org/03svjbs84 |
Funders
Funder type
Charity
The Wellcome Trust (UK) - Training Fellowship (grant ref: 073604)
No information available
Results and Publications
| Intention to publish date | 01/07/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Publication in 2015. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2015 | Yes | No |
Editorial Notes
22/12/2015: Publication reference added.
