Compare Blood Age for TransfusionNCT01580111
Effect of Blood Storage Age on the Resolution of Lactic Acidosis in Children With Severe Malarial Anemia at Mulago Hospital
A study testing Blood transfusion in people with Compare Blood Age for Transfusion, run by Makerere University at 1 site in Uganda.
Trial summary
In resolving lactic acidosis among children with severe malarial anemia, there is no difference between those transfused with blood of longer storage compared to shorter storage age Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Compare Blood Age for Transfusion
- What is being tested?
- Blood transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUganda
- Study dates
- Dec 2010to Nov 2011
- Phase
- Interventional
- 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 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- Children undergoing transfusion with blood products other than packed cells.
- Children with known or concurrent cardiac disease.
Trial locations and contacts
1 site in 1 country.
About this study
In resolving lactic acidosis among children with severe malarial anemia, there is no difference between those transfused with blood of longer storage compared to shorter storage age
Read the detailed description
Objective of the study is to evaluate the effect of blood storage age on resolution of lactic acidosis in children with severe malarial anemia.
Methods:
Children aged 6 - 59 months admitted to ACU with Severe Malarial Anemia (Hb <5g/dl) and Lactic Acidosis (blood lactate >5 mmol /l), will be randomly assigned to receive either blood of shorter storage age (<10 days) or longer storage age (21 -35 days) by gravity infusion as is the routine practice. 37 patients will be enrolled in each study arm. Physiological measurements namely blood lactate, oxygen saturation, Hemoglobin, Blood pressure, respiratory rate and pulse rate will be taken at baseline, during and after transfusion. The two groups will be compared. The primary outcome variable will be the proportion of children whose lactic acidosis resolves after 4 hrs of transfusion. 24hr mortality will be our secondary outcome.
- Conditions
- Compare Blood Age for Transfusion
- Being tested
- Blood transfusion
- Keywords
- Blood, Storage, Age, Transfusion, Lactic acidosis
- Medical subject headings
- Acidosis, Lactic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood transfusionBiological
The short storage arm; children were transfused with packed red cells of storage age 1-10 days; while for the Long storage arm; were transfused with packed red cells of 21- 35 days in storage.
| Study group | Role | What they receive |
|---|---|---|
| Short storage | Experimental | Short storage arm: Will receive blood (Packed red blood cells) of 1 (one) to 10 (ten) days in storage. Receives: Biological: Blood transfusion |
| Long storage arm | Active comparator | Will be transfused with blood ( packed red cells) of storage age 21- 35 days. Receives: Biological: Blood transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of blood storage age on the resolution of lactic acidosis in children with severe malarial anemia at Mulago hospital
The proportion of transfused patients who resolve lactic acidosis within 4 hours of transfusion
Measured: 4hrs
Secondary outcomes (1)
Effect of blood storage age on the resolution of lactic acidosis in children with severe malarial anemia at Mulago hospital
proportion of children who die within 24 hrs.
Measured: 24 HRS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2012 (estimated)
- Study startDec 2010
- Primary completionAug 2011
- Study completionNov 2011
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 Compare Blood Age for TransfusionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faculty of Medicine, Makerere University
- Investigators
- AGGREY DHABANGI, MBChB, M.Med, Principal investigator, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580111
- Sponsor's protocol ID
- AD-001
- Status last verified
- Apr 2012
- First submitted
- 17 Apr 2012
- Last updated
- 18 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dhabangi A, Mworozi E, Lubega IR, Cserti-Gazdewich CM, Maganda A, Dzik WH. The effect of blood storage age on treatment of lactic acidosis by transfusion in children with severe malarial anaemia: a pilot, randomized, controlled trial. Malar J. 2013 Feb 6;12:55. doi: 10.1186/1475-2875-12-55.
PubMed 23388470
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Blood Storage Age on the Resolution of Lactic Acidosis in Children With Severe Malarial Anemia at Mulago Hospital
- ClinicalTrials.gov ID
- NCT01580111
- Acronym / sponsor ID
- AD-001
- Conditions
- Compare Blood Age for Transfusion
- Keywords
- Blood, Storage, Age, Transfusion, Lactic acidosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 18 Apr 2012 (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.
In resolving lactic acidosis among children with severe malarial anemia, there is no difference between those transfused with blood of longer storage compared to shorter storage age
Detailed description
Objective of the study is to evaluate the effect of blood storage age on resolution of lactic acidosis in children with severe malarial anemia.
Methods:
Children aged 6 - 59 months admitted to ACU with Severe Malarial Anemia (Hb <5g/dl) and Lactic Acidosis (blood lactate >5 mmol /l), will be randomly assigned to receive either blood of shorter storage age (<10 days) or longer storage age (21 -35 days) by gravity infusion as is the routine practice. 37 patients will be enrolled in each study arm. Physiological measurements namely blood lactate, oxygen saturation, Hemoglobin, Blood pressure, respiratory rate and pulse rate will be taken at baseline, during and after transfusion. The two groups will be compared. The primary outcome variable will be the proportion of children whose lactic acidosis resolves after 4 hrs of transfusion. 24hr mortality will be our secondary outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short storage | Experimental | Biological: Blood transfusionShort storage arm: Will receive blood (Packed red blood cells) of 1 (one) to 10 (ten) days in storage. |
| Long storage arm | Active comparator | Biological: Blood transfusionWill be transfused with blood ( packed red cells) of storage age 21- 35 days. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Children undergoing transfusion with blood products other than packed cells.
- Children with known or concurrent cardiac disease.
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 |
|---|---|---|
| Blood transfusionThe short storage arm; children were transfused with packed red cells of storage age 1-10 days; while for the Long storage arm; were transfused with packed red cells of 21- 35 days in storage. | Biological | Long storage arm, Short storage |
Primary outcome
Effect of blood storage age on the resolution of lactic acidosis in children with severe malarial anemia at Mulago hospital
Time frame: 4hrs
The proportion of transfused patients who resolve lactic acidosis within 4 hours of transfusion
1 secondary outcome
Effect of blood storage age on the resolution of lactic acidosis in children with severe malarial anemia at Mulago hospital
Time frame: 24 HRS
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 18 Apr 2012.
- Derived from this study: PubMed 23388470Dhabangi A, Mworozi E, Lubega IR, Cserti-Gazdewich CM, Maganda A, Dzik WH. The effect of blood storage age on treatment of lactic acidosis by transfusion in children with severe malarial anaemia: a pilot, randomized, controlled trial. Malar J. 2013 Feb 6;12:55. doi: 10.1186/1475-2875-12-55.
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.
AGGREY DHABANGI, MBChB, M.Med principal investigator
Makerere University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood transfusion in people with Compare Blood Age for Transfusion, run by Makerere University at 1 site 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 0 inclusion and 2 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 18 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Effect of blood storage age on the resolution of lactic acidosis in children with severe malarial anemia at Mulago hospital (time frame: 4hrs). 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 NCT01580111, 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 18 Apr 2012.