Iron, Abnormal Blood LevelNCT02087553
PICU Transfusion Study: Harmful Effects of Red Blood Cell Transfusions
An observational study of Iron, Abnormal Blood Level, run by Columbia University at 2 sites in United States.
Trial summary
The investigators hypothesize that the storage-damaged red cells are responsible for some of the adverse effects of transfusion. In this observational study, the investigators will measure various laboratory parameters both before and after transfusion in a pediatric intensive care unit to determine at what duration… Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Iron, Abnormal Blood Level
- What is being tested?
- Transfusion of red blood cells and Infusion of albumin/saline
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2013to Dec 2018
- Phase
- Observational
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Hospitalized pediatric patients admitted to the Columbia University Medical Center's Pediatric ICU
Who may be able to join
- Less than 21 years of age;
- Greater than 5kg weight;
- Parents or legal guardian have signed informed consent;
- Will be receiving transfusion of packed, leukoreduced RBCs stored in an additive saline (AS) solution (standard practice).
Who cannot join
- Patients have undergone transfusion of platelets or fresh frozen plasma 4 hours before or will receive these products after transfusion of the RBC unit;
- Transfusion of RBC from more than one donor at the test transfusion event.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Columbia University Medical Center
New York, New York, 10032
Weill Cornell Medical College
New York, New York, 10065
About this study
Official title: Harmful Effects of Red Blood Cell Transfusions Are Mediated by Iron: Pediatric ICU Aim
The investigators hypothesize that the storage-damaged red cells are responsible for some of the adverse effects of transfusion. In this observational study, the investigators will measure various laboratory parameters both before and after transfusion in a pediatric intensive care unit to determine at what duration of storage is there laboratory evidence of refrigerator storage damage.
The investigators hypothesize that increasing storage time of packed red blood cells (PRBCs) transfused will be associated with increasing non-transferrin-bound iron (NTBI), pro-inflammatory cytokine concentrations, and enhanced microbial growth in vitro in pediatric patients.
Read the detailed description
Transfusions of red blood cells (RBCs) stored for longer durations are associated with adverse effects in hospitalized patients. During storage, RBCs undergo cumulative changes that reduce their survival in vivo, and have been associated with impairment in oxygen transport and adverse outcomes. Transfusion of older RBCs results in increased NTBI levels in healthy adults, and elevated NTBI levels have been associated with increased morbidity and mortality in hospitalized patients. Transfusion of PRBCs has also been associated with up-regulation of inflammatory cytokines. Pediatric patients are exposed to PRBC transfusions; however, this patient population has not been previously studied for these outcomes.
According to current practice guidelines, PRBCs are stored in the blood bank up to 42 days prior to transfusion. In this study, blood sample will be collected from pediatric ICU patients prior to every PRBC transfusion and again 2-6 hours post-transfusion to determine iron parameters, inflammatory marker concentrations, and growth of microbial pathogens in vitro.
The investigators hopes to further the understanding of the effects of blood storage on outcome in children, thereby making transfusion safer and more effective.
- Conditions
- Iron, Abnormal Blood Level
- Being tested
- Transfusion of red blood cells, Infusion of albumin/saline
- Keywords
- Blood Transfusion, Iron, Packed Red Blood Cells, PRBC, NTBI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transfusion of red blood cellsBiological
Also called Packed Red Blood Cells (PRBCs)
(non-experimental) PRBC transfusion
Infusion of albumin/salineBiological
Also called Albumin/Saline
(non-experimental) albumin/saline infusion
| Study group | Role | What they receive |
|---|---|---|
| Transfused pediatric patients | Children who might receive packed red blood cell (PRBC) transfusion will be enrolled after obtaining consent from their parents/legal guardians and assent from the patient, if possible. Transfusion of red blood cells will be done according to standard of care. Receives: Biological: Transfusion of red blood cells | |
| Saline/Albumin infusion | Children who might receive albumin or saline for volume resuscitation will be enrolled after obtaining consent from their parents/legal guardians and assent from the patient, if possible. Infusion will be done according to standard of care. Receives: Biological: Infusion of albumin/saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-transferrin-bound iron level
Circulating non-transferrin-bound iron level post-transfusion (taken between 2-6 hours post-transfusion and 8-12 hours post-transfusion) vs the pre-transfusion level.
Measured: Up to 12-hours post-transfusion
Secondary outcomes (4)
Hepcidin level
Measured: Up to 12-hours post-transfusion
Level of C-Reactive Protein (CRP)
Measured: Up to 12 hours post-transfusion
Level of Monocyte Chemoattractant Protein (MCP)-1
Measured: Up to 12 hours post-transfusion
Level of Interleukin (IL)-6
Measured: Up to 12 hours post-transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startDec 2013
- Primary completionOct 2014
- Study completionDec 2018
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 Iron, Abnormal Blood LevelStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Eldad Arie Hod, Columbia University
- Investigators
- Eldad A Hod, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087553
- Sponsor's protocol ID
- AAAM5050
- Other IDs
- R01HL115557
- Status last verified
- Mar 2019
- First submitted
- 12 Mar 2014
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
L'Acqua C, Bandyopadhyay S, Francis RO, McMahon DJ, Nellis M, Sheth S, Kernie SG, Brittenham GM, Spitalnik SL, Hod EA. Red blood cell transfusion is associated with increased hemolysis and an acute phase response in a subset of critically ill children. Am J Hematol. 2015 Oct;90(10):915-20. doi: 10.1002/ajh.24119.
PubMed 26183122
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harmful Effects of Red Blood Cell Transfusions Are Mediated by Iron: Pediatric ICU Aim
- ClinicalTrials.gov ID
- NCT02087553
- Acronym / sponsor ID
- AAAM5050
- Conditions
- Iron, Abnormal Blood Level
- Keywords
- Blood Transfusion, Iron, Packed Red Blood Cells, PRBC, NTBI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Dec 2013 (actual)
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 14 Mar 2014 (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 investigators hypothesize that the storage-damaged red cells are responsible for some of the adverse effects of transfusion. In this observational study, the investigators will measure various laboratory parameters both before and after transfusion in a pediatric intensive care unit to determine at what duration of storage is there laboratory evidence of refrigerator storage damage.
The investigators hypothesize that increasing storage time of packed red blood cells (PRBCs) transfused will be associated with increasing non-transferrin-bound iron (NTBI), pro-inflammatory cytokine concentrations, and enhanced microbial growth in vitro in pediatric patients.
Detailed description
Transfusions of red blood cells (RBCs) stored for longer durations are associated with adverse effects in hospitalized patients. During storage, RBCs undergo cumulative changes that reduce their survival in vivo, and have been associated with impairment in oxygen transport and adverse outcomes. Transfusion of older RBCs results in increased NTBI levels in healthy adults, and elevated NTBI levels have been associated with increased morbidity and mortality in hospitalized patients. Transfusion of PRBCs has also been associated with up-regulation of inflammatory cytokines. Pediatric patients are exposed to PRBC transfusions; however, this patient population has not been previously studied for these outcomes.
According to current practice guidelines, PRBCs are stored in the blood bank up to 42 days prior to transfusion. In this study, blood sample will be collected from pediatric ICU patients prior to every PRBC transfusion and again 2-6 hours post-transfusion to determine iron parameters, inflammatory marker concentrations, and growth of microbial pathogens in vitro.
The investigators hopes to further the understanding of the effects of blood storage on outcome in children, thereby making transfusion safer and more effective.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transfused pediatric patients | – | Biological: Transfusion of red blood cellsChildren who might receive packed red blood cell (PRBC) transfusion will be enrolled after obtaining consent from their parents/legal guardians and assent from the patient, if possible. Transfusion of red blood cells will be done according to standard of care. |
| Saline/Albumin infusion | – | Biological: Infusion of albumin/salineChildren who might receive albumin or saline for volume resuscitation will be enrolled after obtaining consent from their parents/legal guardians and assent from the patient, if possible. Infusion will be done according to standard of care. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Hospitalized pediatric patients admitted to the Columbia University Medical Center's Pediatric ICU
Key inclusion criteria (4 listed)
- Less than 21 years of age;
- Greater than 5kg weight;
- Parents or legal guardian have signed informed consent;
- Will be receiving transfusion of packed, leukoreduced RBCs stored in an additive saline (AS) solution (standard practice).
Key exclusion criteria (2 listed)
- Patients have undergone transfusion of platelets or fresh frozen plasma 4 hours before or will receive these products after transfusion of the RBC unit;
- Transfusion of RBC from more than one donor at the test transfusion event.
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 |
|---|---|---|
| Transfusion of red blood cellsAlso: Packed Red Blood Cells (PRBCs)(non-experimental) PRBC transfusion | Biological | Transfused pediatric patients |
| Infusion of albumin/salineAlso: Albumin/Saline(non-experimental) albumin/saline infusion | Biological | Saline/Albumin infusion |
Primary outcome
Non-transferrin-bound iron level
Time frame: Up to 12-hours post-transfusion
Circulating non-transferrin-bound iron level post-transfusion (taken between 2-6 hours post-transfusion and 8-12 hours post-transfusion) vs the pre-transfusion level.
4 secondary outcomes
Hepcidin level
Time frame: Up to 12-hours post-transfusion
Level of C-Reactive Protein (CRP)
Time frame: Up to 12 hours post-transfusion
Level of Monocyte Chemoattractant Protein (MCP)-1
Time frame: Up to 12 hours post-transfusion
Level of Interleukin (IL)-6
Time frame: Up to 12 hours post-transfusion
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 27 Mar 2019.
- Results publication: PubMed 26183122L'Acqua C, Bandyopadhyay S, Francis RO, McMahon DJ, Nellis M, Sheth S, Kernie SG, Brittenham GM, Spitalnik SL, Hod EA. Red blood cell transfusion is associated with increased hemolysis and an acute phase response in a subset of critically ill children. Am J Hematol. 2015 Oct;90(10):915-20. doi: 10.1002/ajh.24119.
- Individual participant dataSharing planned: Undecided
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.
Eldad A Hod, MD principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron, Abnormal Blood Level, run by Columbia University at 2 sites in United States.
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 4 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 27 Mar 2019. 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 United States. 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?
Non-transferrin-bound iron level (time frame: Up to 12-hours post-transfusion). 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 NCT02087553, 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 27 Mar 2019.