Iron, Abnormal Blood LevelNCT01319552

Fresh Versus Old Red Blood Cells for Transfusion

A study testing Fresh transfusion and Old transfusion in people with Iron, Abnormal Blood Level and Other Abnormal Blood Chemistry, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Iron, Abnormal Blood Level, Other Abnormal Blood Chemistry
What is being tested?: Fresh transfusion and Old transfusion
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: Dec 2008to Oct 2010
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

healthy
male body weight >130 lbs, female body weight > 155 lbs
male height >5'1", female height >5'5"
hemoglobin >13.3 g/dL

Who cannot join

ineligible for donation based on the New York Blood Center autologous 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
positive results on standard blood donor infectious disease testing
pregnancy.

Trial locations and contacts

1 site in 1 country.

United States1 site

Columbia University Medical Center
New York, New York, 10032

Other trials in United States

About this study

Official title: Immunomodulatory Properties of Fresh Versus Stored Packed Red Blood Cells for Transfusion

Packed red blood cell units destined for transfusion can be stored for up to 42 days prior to transfusion based on Food and Drug Administration (FDA) guidelines. Recent studies suggest that certain patients transfused with blood stored for longer duration have poorer outcomes than patients transfused fresher blood. The investigators' hypothesis is that the delivery of an immediate and substantial load of hemoglobin-associated iron from a stored unit of blood leads to changes that explain the differences in outcome between patients transfused old versus fresh blood. The investigators propose to test this hypothesis in humans by transfusing an individual's own blood, both fresh and after storage, and comparing levels of various outcome measures.

Read the detailed description

Participants in this study will be asked to participate in a standard blood donation. The blood will be processed per standards at the investigators regional blood center (New York Blood Center) and then split into two equal units and shipped to Columbia University Medical Center for storage and transfusion. One unit will be transfused back into the same individual fresh (i.e. between 3-7 days after donation). The other unit will be transfused 42 days after donation. Blood samples will be drawn before, during, and after transfusion to measure levels of various analytes.

Conditions: Iron, Abnormal Blood Level, Other Abnormal Blood Chemistry
Being tested: Fresh transfusion, Old transfusion
Keywords: red blood cells, transfusion, storage, sickle cell disease, β-thalassemia, hemoglobin-associated iron
Medical subject headings: Anemia, Sickle Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fresh transfusionProcedure or surgery
Also called Stored transfusion
1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions
Old transfusionProcedure or surgery
Also called Stored transfusion
1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions

Study groups in NCT01319552
Study group	Role	What they receive
Fresh transfusion	Other	1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions Receives: Procedure: Fresh transfusion; Procedure: Old transfusion
Old transfusion	Experimental	1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions Receives: Procedure: Fresh transfusion; Procedure: Old transfusion

What is being measured

The primary outcome is the main question the study is designed to answer.

Measure of Non-transferrin-bound Iron
Comparison of increase in non-transferrin-bound iron for each participant between his or her "fresh" and "old" blood transfusion four hours after transfusion.
Measured: four hours after transfusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2008Oct 2010

First posted21 Mar 2011 (estimated)
Study startDec 2008
Primary completionOct 2010
Study completionOct 2010

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, 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01319552
Sponsor's protocol ID: AAAD3737
Other IDs: R01HL098014
Status last verified: May 2015
First submitted: 18 Mar 2011
Last updated: 2 Jun 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Hod EA, Brittenham GM, Billote GB, Francis RO, Ginzburg YZ, Hendrickson JE, Jhang J, Schwartz J, Sharma S, Sheth S, Sireci AN, Stephens HL, Stotler BA, Wojczyk BS, Zimring JC, Spitalnik SL. Transfusion of human volunteers with older, stored red blood cells produces extravascular hemolysis and circulating non-transferrin-bound iron. Blood. 2011 Dec 15;118(25):6675-82. doi: 10.1182/blood-2011-08-371849. Epub 2011 Oct 20.
PubMed 22021369

Study at a glance

From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunomodulatory Properties of Fresh Versus Stored Packed Red Blood Cells for Transfusion
ClinicalTrials.gov ID: NCT01319552
Acronym / sponsor ID: AAAD3737
Conditions: Iron, Abnormal Blood Level, Other Abnormal Blood Chemistry
Keywords: red blood cells, transfusion, storage, sickle cell disease, β-thalassemia, hemoglobin-associated iron
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Columbia UniversityUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: Dec 2008
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 21 Mar 2011 (estimated)
Results: Posted 2 Jun 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Fresh transfusion	Other	Procedure: Fresh transfusion, Procedure: Old transfusion1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions
Old transfusion	Experimental	Procedure: Fresh transfusion, Procedure: Old transfusion1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

healthy
male body weight >130 lbs, female body weight > 155 lbs
male height >5'1", female height >5'5"
hemoglobin >13.3 g/dL

Key exclusion criteria (8 listed)

ineligible for donation based on the New York Blood Center autologous 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

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
Fresh transfusionAlso: Stored transfusion1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions	Procedure or surgery	Fresh transfusion, Old transfusion
Old transfusionAlso: Stored transfusion1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions	Procedure or surgery	Fresh transfusion, Old transfusion

Primary outcome

Measure of Non-transferrin-bound Iron
Time frame: four hours after transfusion
Comparison of increase in non-transferrin-bound iron for each participant between his or her "fresh" and "old" blood transfusion four hours after transfusion.

Results and safety

Results posted to the registry on 2 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Transfusion	14	14

Primary outcome: Measure of Non-transferrin-bound Iron

Time frame: four hours after transfusion. Mean (Standard Deviation). Unit: μM

Measure	Fresh Transfusion n = 14	Old Transfusion n = 14
Value	0.16 (0.99)	3.17 (3.26)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Transfusion	0 of 14 (0%)	3 of 14 (21.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22021369Hod EA, Brittenham GM, Billote GB, Francis RO, Ginzburg YZ, Hendrickson JE, Jhang J, Schwartz J, Sharma S, Sheth S, Sireci AN, Stephens HL, Stotler BA, Wojczyk BS, Zimring JC, Spitalnik SL. Transfusion of human volunteers with older, stored red blood cells produces extravascular hemolysis and circulating non-transferrin-bound iron. Blood. 2011 Dec 15;118(25):6675-82. doi: 10.1182/blood-2011-08-371849. Epub 2011 Oct 20.

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.

Spitalnik 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 Fresh transfusion and Old transfusion in people with Iron, Abnormal Blood Level and Other Abnormal Blood Chemistry, 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 4 inclusion and 8 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 2 Jun 2015. 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 2 Jun 2015). 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?

Measure of Non-transferrin-bound Iron (time frame: four hours 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 NCT01319552, 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 2 Jun 2015.