Condition category
Haematological Disorders
Date applied
01/07/2007
Date assigned
05/07/2007
Last edited
22/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Oliver Hassall

ORCID ID

Contact details

KEMRI/Wellcome Trust Research Laboratories
PO Box 230
Kilifi
80108
Kenya
-
ohassall@kilifi.kemri-wellcome.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SSC 1215

Study information

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

Acronym

Study hypothesis

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

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)

Study design

Phase 1b, open-label, non-randomised, non-controlled, single arm trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Umbilical cord blood transfusion

Primary outcome measures

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 trial start date

25/06/2007

Overall trial end date

17/06/2008

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

80

Participant 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

Recruitment start date

25/06/2007

Recruitment end date

17/06/2008

Locations

Countries of recruitment

Kenya

Trial participating centre

KEMRI/Wellcome Trust Research Laboratories
Kilifi
80108
Kenya

Sponsor information

Organisation

Liverpool School of Tropical Medicine (UK)

Sponsor details

c/o Professor Janet Hemingway
Pembroke Place
Liverpool
L3 5QA
United Kingdom
+44 (0)151 705 3370
hemingway@liverpool.ac.uk

Sponsor type

University/education

Website

http://www.liv.ac.uk/lstm/

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) - Training Fellowship (grant ref: 073604)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publication in 2015.

Intention to publish date

01/07/2015

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26687795

Publication citations

Additional files

Editorial Notes

22/12/2015: Publication reference added.