AnemiaPhase 3TOTALNCT01586923
RBC Transfusion in Severe Anemia With Lactic Acidosis
A Phase 3 study testing RBC transfusion in people with Anemia, run by Massachusetts General Hospital at 1 site in Uganda.
Trial summary
The hypothesis of this study is that prolonged-storage RBCs are not inferior to short-storage RBCs for the time required to clear elevated blood lactate levels in children with severe anemia. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Anemia
- What is being tested?
- RBC transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteUganda
- Study dates
- Feb 2013to Apr 2016
- Phase
- Phase 3
- 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 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6 mos to 5 years
- Hg < 5 g/dL and Lactate > 5 mM
Who cannot join
- Receiving transfusion other than RBCs
- Children with known or suspected cardiac disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study of RBC Transfusion in Children With Severe Anemia
The hypothesis of this study is that prolonged-storage RBCs are not inferior to short-storage RBCs for the time required to clear elevated blood lactate levels in children with severe anemia.
Read the detailed description
This study will measure the time to resolution of lactic acidosis in patients with severe anemia following blood transfusion.
- Conditions
- Anemia
- Being tested
- RBC transfusion
- Keywords
- Anemia, Transfusion, RBC storage age, Tissue oxygenation, Malaria
- Medical subject headings
- Anemia, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBC transfusionBiological
RBC transfusion of different storage age
| Study group | Role | What they receive |
|---|---|---|
| Short-storage RBC | Active comparator | RBC transfusion using packed RBCs stored for 10 days or less. Receives: Biological: RBC transfusion |
| Prolonged-storage RBC | Active comparator | RBC transfusion using packed RBCs stored for 25 days or more. Receives: Biological: RBC transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of elevated levels of blood lactate during 24 following RBC transfusion
Measured: 24 hours
Secondary outcomes (2)
Normalization of vital signs
Measured: 24 hours
Correction of acidosis
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 posted27 Apr 2012 (estimated)
- Study startFeb 2013
- Primary completionMay 2015
- Study completionApr 2016
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 AnemiaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walter H. Dzik, Massachusetts General Hospital
- Investigators
- Walter H Dzik, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586923
- Sponsor's protocol ID
- R21
- Acronym
- TOTAL
- Status last verified
- Apr 2016
- First submitted
- 25 Apr 2012
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Data published
Publications
Dhabangi A, Ainomugisha B, Cserti-Gazdewich C, Ddungu H, Kyeyune D, Musisi E, Opoka R, Stowell CP, Dzik WH. Effect of Transfusion of Red Blood Cells With Longer vs Shorter Storage Duration on Elevated Blood Lactate Levels in Children With Severe Anemia: The TOTAL Randomized Clinical Trial. JAMA. 2015 Dec 15;314(23):2514-23. doi: 10.1001/jama.2015.13977.
PubMed 26637812
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of RBC Transfusion in Children With Severe Anemia
- ClinicalTrials.gov ID
- NCT01586923
- Acronym / sponsor ID
- TOTAL / R21
- Conditions
- Anemia
- Keywords
- Anemia, Transfusion, RBC storage age, Tissue oxygenation, Malaria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 27 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.
The hypothesis of this study is that prolonged-storage RBCs are not inferior to short-storage RBCs for the time required to clear elevated blood lactate levels in children with severe anemia.
Detailed description
This study will measure the time to resolution of lactic acidosis in patients with severe anemia following blood transfusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short-storage RBC | Active comparator | Biological: RBC transfusionRBC transfusion using packed RBCs stored for 10 days or less. |
| Prolonged-storage RBC | Active comparator | Biological: RBC transfusionRBC transfusion using packed RBCs stored for 25 days or more. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 6 mos to 5 years
- Hg < 5 g/dL and Lactate > 5 mM
Key exclusion criteria (2 listed)
- Receiving transfusion other than RBCs
- Children with known or suspected 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 |
|---|---|---|
| RBC transfusionRBC transfusion of different storage age | Biological | Prolonged-storage RBC, Short-storage RBC |
Primary outcome
Reduction of elevated levels of blood lactate during 24 following RBC transfusion
Time frame: 24 hours
2 secondary outcomes
Normalization of vital signs
Time frame: 24 hours
Correction of acidosis
Time frame: 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 8 Apr 2016.
- Derived from this study: PubMed 26637812Dhabangi A, Ainomugisha B, Cserti-Gazdewich C, Ddungu H, Kyeyune D, Musisi E, Opoka R, Stowell CP, Dzik WH. Effect of Transfusion of Red Blood Cells With Longer vs Shorter Storage Duration on Elevated Blood Lactate Levels in Children With Severe Anemia: The TOTAL Randomized Clinical Trial. JAMA. 2015 Dec 15;314(23):2514-23. doi: 10.1001/jama.2015.13977.
- Individual participant dataSharing planned: No. Data published
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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.
Walter H Dzik, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RBC transfusion in people with Anemia, run by Massachusetts General Hospital 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 2 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 8 Apr 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Reduction of elevated levels of blood lactate during 24 following RBC transfusion (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 NCT01586923, 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 8 Apr 2016.