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

ISRCTN	ISRCTN66687527
DOI	https://doi.org/10.1186/ISRCTN66687527
Protocol serial number	SSC 1215
Sponsor	Liverpool School of Tropical Medicine (UK)
Funder	The Wellcome Trust (UK) - Training Fellowship (grant ref: 073604)

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

KEMRI/Wellcome Trust Research Laboratories
PO Box 230
Kilifi
80108
Kenya

Email	ohassall@kilifi.kemri-wellcome.org

Study information

Primary study design	Interventional
Study design	Phase 1b, open-label, non-randomised, non-controlled, single arm trial
Secondary study design	Non randomised controlled trial
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
Phase	Phase I/II
Drug / device / biological / vaccine name(s)	Umbilical cord blood transfusion
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Rise in haemoglobin at 24 hours and 28 days.
Completion date	17/06/2008

Eligibility

Participant type(s)	Patient
Age group	Child
Upper age limit	12 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
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.