Iron, Blood Level AbnormalNCT02087514
Duration of Red Blood Cell Storage Prior to Transfusion
A study testing Blood Transfusion and Packed red blood cells in people with Iron, Blood Level Abnormal, run by Columbia University at 1 site in United States.
Trial summary
This study will determine the minimal duration of red blood cell (RBC) storage that leads to increases in circulating non-transferrin-bound iron in healthy human volunteers post-transfusion. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron, Blood Level Abnormal
- What is being tested?
- Blood Transfusion and Packed red blood cells
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Feb 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years old
- Body weight >110 lbs
- Hemoglobin >12.5 g/dL
Who cannot join
- Ineligible for donation based on the New York Blood Center blood donor questionnaire
- Systolic blood pressure >180 or <90 mm Hg, diastolic blood pressure >100 or <50 mm Hg
- Heart rate <50 or >100
- Temperature >99.5 F prior to donation
- Temperature >100.4 F or subjective feeling of illness prior to transfusion (this is to avoid having a concurrent illness affect post-transfusion measurements);
- Positive results on standard blood donor infectious disease testing
- Positive urine pregnancy test
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Duration of Red Blood Cell Storage Prior to Transfusion and Non-Transferrin-Bound Iron
This study will determine the minimal duration of red blood cell (RBC) storage that leads to increases in circulating non-transferrin-bound iron in healthy human volunteers post-transfusion. The results from this study will help guide national guidelines for appropriate duration of RBC storage prior to transfusion, which is currently 6 weeks by Food and Drug Administration (FDA) criteria. The overall objective of this research is to improve the safety of refrigerated storage of red blood cells before transfusion.
Read the detailed description
Recent studies suggest that older stored blood is associated with worse outcomes in certain hospitalized patients. Red cells may be stored in a refrigerator prior to transfusion for up to 42 days by current FDA standards. Refrigerator storage of red cells is associated with a storage lesion and the survival of transfused red cells decreases with increasing storage time, thus older blood is associated with an increased delivery of hemoglobin-iron to certain parts of the body. The investigators have preliminary data in mice and humans suggesting that delivery of a significant iron load from aged red cells leads to the production of a potentially toxic form of circulating iron called non-transferrin-bound iron.
In this prospective study of healthy volunteers, each subject will be randomized to receive transfusion of one RBC unit after 1, 2, 3, 4, 5, or 6 weeks of storage. The primary outcome will be the 24 hr area under the curve (AUC) of the serum non-transferrin bound iron concentration calculated from samples collected at 0, 2, 4, 6, 8, 10, 12, 14 and 24 hours after transfusion.
- Conditions
- Iron, Blood Level Abnormal
- Being tested
- Blood Transfusion, Packed red blood cells
- Keywords
- Blood Transfusion, Iron, Red Blood Cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood TransfusionProcedure or surgery
Also called Red blood cell (RBC) transfusion
A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.
Packed red blood cellsOther
Also called PRBC
Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.
A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.
The number of weeks in storage are as follows:
- 1 week
- 2 weeks
- 3 weeks
- 4 weeks
- 5 weeks
- 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Transfusion of PRBC stored for 1 week | Active comparator | Subjects will receive blood transfusion with packed red blood cells stored for 1 week. Receives: Procedure: Blood Transfusion; Other: Packed red blood cells |
| Transfusion of PRBC stored for 2 weeks | Experimental | Subjects will receive blood transfusion with packed red blood cells stored for 2 weeks. Receives: Procedure: Blood Transfusion; Other: Packed red blood cells |
| Transfusion of PRBC stored for 3 weeks | Experimental | Subjects will receive blood transfusion with packed red blood cells stored for 3 weeks. Receives: Procedure: Blood Transfusion; Other: Packed red blood cells |
| Transfusion of PRBC stored for 4 weeks | Experimental | Subjects will receive blood transfusion with packed red blood cells stored for 4 weeks. Receives: Procedure: Blood Transfusion; Other: Packed red blood cells |
| Transfusion of PRBC stored for 5 weeks | Experimental | Subjects will receive blood transfusion with packed red blood cells stored for 5 weeks. Receives: Procedure: Blood Transfusion; Other: Packed red blood cells |
| Transfusion of PRBC stored for 6 weeks | Experimental | Subjects will receive blood transfusion with packed red blood cells stored for 6 weeks. Receives: Procedure: Blood Transfusion; Other: Packed red blood cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-transferrin-bound Iron Level (AUC)
Area under the curve of change of Non-transferrin-bound iron from immediately after transfusion to end of observation (i.e., from 0-hr after transfusion to 24-hr after transfusion).
Measured: 0, 2, 4, 6, 8, 10, 12, 14 and 24 after 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 startFeb 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron, Blood Level AbnormalStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 60 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, Steven L. Spitalnik, Columbia University
- Investigators
- Steven L Spitalnik, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087514
- Sponsor's protocol ID
- AAAI0835
- Other IDs
- R01HL115557
- Status last verified
- Mar 2018
- First submitted
- 12 Mar 2014
- Last updated
- 19 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rapido F, Brittenham GM, Bandyopadhyay S, La Carpia F, L'Acqua C, McMahon DJ, Rebbaa A, Wojczyk BS, Netterwald J, Wang H, Schwartz J, Eisenberger A, Soffing M, Yeh R, Divgi C, Ginzburg YZ, Shaz BH, Sheth S, Francis RO, Spitalnik SL, Hod EA. Prolonged red cell storage before transfusion increases extravascular hemolysis. J Clin Invest. 2017 Jan 3;127(1):375-382. doi: 10.1172/JCI90837. Epub 2016 Dec 12.
PubMed 27941245
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Red Blood Cell Storage Prior to Transfusion and Non-Transferrin-Bound Iron
- ClinicalTrials.gov ID
- NCT02087514
- Acronym / sponsor ID
- AAAI0835
- Conditions
- Iron, Blood Level Abnormal
- Keywords
- Blood Transfusion, Iron, Red Blood Cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2014 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Posted 20 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the minimal duration of red blood cell (RBC) storage that leads to increases in circulating non-transferrin-bound iron in healthy human volunteers post-transfusion. The results from this study will help guide national guidelines for appropriate duration of RBC storage prior to transfusion, which is currently 6 weeks by Food and Drug Administration (FDA) criteria. The overall objective of this research is to improve the safety of refrigerated storage of red blood cells before transfusion.
Detailed description
Recent studies suggest that older stored blood is associated with worse outcomes in certain hospitalized patients. Red cells may be stored in a refrigerator prior to transfusion for up to 42 days by current FDA standards. Refrigerator storage of red cells is associated with a storage lesion and the survival of transfused red cells decreases with increasing storage time, thus older blood is associated with an increased delivery of hemoglobin-iron to certain parts of the body. The investigators have preliminary data in mice and humans suggesting that delivery of a significant iron load from aged red cells leads to the production of a potentially toxic form of circulating iron called non-transferrin-bound iron.
In this prospective study of healthy volunteers, each subject will be randomized to receive transfusion of one RBC unit after 1, 2, 3, 4, 5, or 6 weeks of storage. The primary outcome will be the 24 hr area under the curve (AUC) of the serum non-transferrin bound iron concentration calculated from samples collected at 0, 2, 4, 6, 8, 10, 12, 14 and 24 hours after transfusion.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Transfusion of PRBC stored for 1 week | Active comparator | Procedure: Blood Transfusion, Other: Packed red blood cellsSubjects will receive blood transfusion with packed red blood cells stored for 1 week. |
| Transfusion of PRBC stored for 2 weeks | Experimental | Procedure: Blood Transfusion, Other: Packed red blood cellsSubjects will receive blood transfusion with packed red blood cells stored for 2 weeks. |
| Transfusion of PRBC stored for 3 weeks | Experimental | Procedure: Blood Transfusion, Other: Packed red blood cellsSubjects will receive blood transfusion with packed red blood cells stored for 3 weeks. |
| Transfusion of PRBC stored for 4 weeks | Experimental | Procedure: Blood Transfusion, Other: Packed red blood cellsSubjects will receive blood transfusion with packed red blood cells stored for 4 weeks. |
| Transfusion of PRBC stored for 5 weeks | Experimental | Procedure: Blood Transfusion, Other: Packed red blood cellsSubjects will receive blood transfusion with packed red blood cells stored for 5 weeks. |
| Transfusion of PRBC stored for 6 weeks | Experimental | Procedure: Blood Transfusion, Other: Packed red blood cellsSubjects will receive blood transfusion with packed red blood cells stored for 6 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 years old
- Body weight >110 lbs
- Hemoglobin >12.5 g/dL
Key exclusion criteria (7 listed)
- Ineligible for donation based on the New York Blood Center blood donor questionnaire
- Systolic blood pressure >180 or <90 mm Hg, diastolic blood pressure >100 or <50 mm Hg
- Heart rate <50 or >100
- Temperature >99.5 F prior to donation
- Temperature >100.4 F or subjective feeling of illness prior to transfusion (this is to avoid having a concurrent illness affect post-transfusion measurements);
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 TransfusionAlso: Red blood cell (RBC) transfusionA routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. | Procedure or surgery | Transfusion of PRBC stored for 1 week, Transfusion of PRBC stored for 2 weeks, Transfusion of PRBC stored for 3 weeks, Transfusion of PRBC stored for 4 weeks, Transfusion of PRBC stored for 5 weeks, Transfusion of PRBC stored for 6 weeks |
| Packed red blood cellsAlso: PRBCRed blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion. A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank. The number of weeks in storage are as follows: * 1 week * 2 weeks * 3 weeks * 4 weeks * 5 weeks * 6 weeks | Other | Transfusion of PRBC stored for 1 week, Transfusion of PRBC stored for 2 weeks, Transfusion of PRBC stored for 3 weeks, Transfusion of PRBC stored for 4 weeks, Transfusion of PRBC stored for 5 weeks, Transfusion of PRBC stored for 6 weeks |
Primary outcome
Non-transferrin-bound Iron Level (AUC)
Time frame: 0, 2, 4, 6, 8, 10, 12, 14 and 24 after transfusion
Area under the curve of change of Non-transferrin-bound iron from immediately after transfusion to end of observation (i.e., from 0-hr after transfusion to 24-hr after transfusion).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27941245Rapido F, Brittenham GM, Bandyopadhyay S, La Carpia F, L'Acqua C, McMahon DJ, Rebbaa A, Wojczyk BS, Netterwald J, Wang H, Schwartz J, Eisenberger A, Soffing M, Yeh R, Divgi C, Ginzburg YZ, Shaz BH, Sheth S, Francis RO, Spitalnik SL, Hod EA. Prolonged red cell storage before transfusion increases extravascular hemolysis. J Clin Invest. 2017 Jan 3;127(1):375-382. doi: 10.1172/JCI90837. Epub 2016 Dec 12.
- 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.
Steven L Spitalnik, MD principal investigator
Columbia 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 and Packed red blood cells in people with Iron, Blood Level Abnormal, run by Columbia University at 1 site 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 3 inclusion and 7 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 19 Apr 2018. 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 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?
Yes. Results are posted in the registry (first posted 20 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (AUC) (time frame: 0, 2, 4, 6, 8, 10, 12, 14 and 24 after 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 NCT02087514, 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 19 Apr 2018.