Severe AnaemiaPhase 2Tx30NCT01461590
Study of Safe Blood Transfusion Volumes to Correct Acute Severe Anaemia
A Phase 2 study testing Whole blood in people with Severe Anaemia, run by Prof Kathryn Maitland at 2 sites in Uganda.
Trial summary
Greater volume of whole blood(30mls/kg compared to 20mls/kg) following standard calculations, given to children with severe anaemia will be beneficial in haematological correction and can be given safely since respiratory distress and haemodynamic changes result from acidosis and compensation in these children rather… Read more about this study
- Who is it for?
- Ages 60 days to 12 years
- Conditions the study is for
- Severe Anaemia
- What is being tested?
- Whole blood
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesUganda
- Study dates
- Oct 2011to Jan 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 days to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Severe anaemia(HB less than 6g/dl)at admission
- Guardian or parent willing/able to provide consent
Who cannot join
- Malignancy
- Surgery
- Acute trauma
- Severe malnutrition
Trial locations and contacts
2 sites in 1 country.
Uganda2 sites
Mbale Regional Referral Hospital
Mbale, Mbale
Soroti Regional Hospital
Soroti, Soroti
About this study
Official title: Phase II Trial of Transfusion Volumes in Children With Acute Severe Anaemia
Greater volume of whole blood(30mls/kg compared to 20mls/kg) following standard calculations, given to children with severe anaemia will be beneficial in haematological correction and can be given safely since respiratory distress and haemodynamic changes result from acidosis and compensation in these children rather than from biventricular failure.
Read the detailed description
Severe anemia (SA, hemoglobin <6 g/dl) is a leading cause of pediatric hospital admission in Africa, with significant in-hospital mortality. The underlying etiology is often infectious, but specific pathogens are rarely identified. Guidelines developed to encourage rational blood use recommend a standard volume of whole blood (20 ml/kg) for transfusion, but this is commonly associated with a frequent need for repeat transfusion and poor outcome. Evidence is lacking on what haemoglobin threshold criteria for intervention and volume are associated with the optimal survival outcomes.
We evaluated the safety and efficacy of a higher volume of whole blood (30 ml/kg; Tx30: n = 78) against the standard volume (20 ml/kg; Tx20: n = 82) in Ugandan children (median age 35.5 months (interquartile range (IQR) 12.5 to 52.5)) for 24-hour anemia correction (hemoglobin >6 g/dl: primary outcome) and 28-day survival.
- Conditions
- Severe Anaemia
- Being tested
- Whole blood
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole bloodOther
30mls/kg transfused over fours hours
Whole bloodOther
20mls/kg transfused over four hours
| Study group | Role | What they receive |
|---|---|---|
| 20ml/kg of whole blood transfusion | Active comparator | Standard care recommended by WHO Receives: Other: Whole blood |
| 30ml/kg of whole blood | Experimental | Higher volume than currently recommended Receives: Other: Whole blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correction of severe anaemia.
Correction of severe anaemia to a Hb >6g/dL at 24 hours.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe AnaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof Kathryn Maitland
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London
- Responsible party
- Sponsor-investigator, Prof Kathryn Maitland, KEMRI-Wellcome Trust Collaborative Research Program
- Investigators
- Charles Engoru, MMed, MBChB, Principal investigator, Soroti Regional Hospital, Uganda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461590
- Sponsor's protocol ID
- KEMRI_CT_2011/0015
- Acronym
- Tx30
- Status last verified
- Mar 2015
- First submitted
- 26 Oct 2011
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Olupot-Olupot P, Engoru C, Thompson J, Nteziyaremye J, Chebet M, Ssenyondo T, Dambisya CM, Okuuny V, Wokulira R, Amorut D, Ongodia P, Mpoya A, Williams TN, Uyoga S, Macharia A, Gibb DM, Walker AS, Maitland K. Phase II trial of standard versus increased transfusion volume in Ugandan children with acute severe anemia. BMC Med. 2014 Apr 25;12:67. doi: 10.1186/1741-7015-12-67.
PubMed 24767094
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Transfusion Volumes in Children With Acute Severe Anaemia
- ClinicalTrials.gov ID
- NCT01461590
- Acronym / sponsor ID
- Tx30 / KEMRI_CT_2011/0015
- Conditions
- Severe Anaemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Prof Kathryn MaitlandUniversity, hospital or other
- Collaborators
- Imperial College London
- Study start
- Oct 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 28 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Greater volume of whole blood(30mls/kg compared to 20mls/kg) following standard calculations, given to children with severe anaemia will be beneficial in haematological correction and can be given safely since respiratory distress and haemodynamic changes result from acidosis and compensation in these children rather than from biventricular failure.
Detailed description
Severe anemia (SA, hemoglobin <6 g/dl) is a leading cause of pediatric hospital admission in Africa, with significant in-hospital mortality. The underlying etiology is often infectious, but specific pathogens are rarely identified. Guidelines developed to encourage rational blood use recommend a standard volume of whole blood (20 ml/kg) for transfusion, but this is commonly associated with a frequent need for repeat transfusion and poor outcome. Evidence is lacking on what haemoglobin threshold criteria for intervention and volume are associated with the optimal survival outcomes.
We evaluated the safety and efficacy of a higher volume of whole blood (30 ml/kg; Tx30: n = 78) against the standard volume (20 ml/kg; Tx20: n = 82) in Ugandan children (median age 35.5 months (interquartile range (IQR) 12.5 to 52.5)) for 24-hour anemia correction (hemoglobin >6 g/dl: primary outcome) and 28-day survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20ml/kg of whole blood transfusion | Active comparator | Other: Whole bloodStandard care recommended by WHO |
| 30ml/kg of whole blood | Experimental | Other: Whole bloodHigher volume than currently recommended |
Who may qualify
- Ages
- 60 days to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Severe anaemia(HB less than 6g/dl)at admission
- Guardian or parent willing/able to provide consent
Key exclusion criteria (4 listed)
- Malignancy
- Surgery
- Acute trauma
- Severe malnutrition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole blood30mls/kg transfused over fours hours | Other | 20ml/kg of whole blood transfusion, 30ml/kg of whole blood |
| Whole blood20mls/kg transfused over four hours | Other | 20ml/kg of whole blood transfusion, 30ml/kg of whole blood |
Primary outcome
Correction of severe anaemia.
Time frame: 24 hours
Correction of severe anaemia to a Hb >6g/dL at 24 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
- Derived from this study: PubMed 24767094Olupot-Olupot P, Engoru C, Thompson J, Nteziyaremye J, Chebet M, Ssenyondo T, Dambisya CM, Okuuny V, Wokulira R, Amorut D, Ongodia P, Mpoya A, Williams TN, Uyoga S, Macharia A, Gibb DM, Walker AS, Maitland K. Phase II trial of standard versus increased transfusion volume in Ugandan children with acute severe anemia. BMC Med. 2014 Apr 25;12:67. doi: 10.1186/1741-7015-12-67.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Engoru, MMed, MBChB principal investigator
Soroti Regional Hospital, Uganda
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Whole blood in people with Severe Anaemia, run by Prof Kathryn Maitland at 2 sites in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correction of severe anaemia. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01461590, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.