Sickle Cell DiseaseNCT01534676
Effects of Transfusion of Older Stored Red Cells
A study testing Transfusion, Blood and Chelation therapy in people with Sickle Cell Disease and Thalassemia, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of transfusion of fresh and stored blood on patients. The investigators hope to test: whether a similar effect (older stored blood is associated with worse outcomes) is seen in chronically transfused patients with hemoglobinopathies. Read more about this study
- Who is it for?
- Ages 1 year to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease, Thalassemia
- What is being tested?
- Transfusion, Blood and Chelation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Mar 2013
- 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 1 year to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- specific, well-characterized hemoglobinopathy
- chronic simple transfusion therapy (transfusion episodes < 6 weeks apart in frequency)
- chronic iron chelation therapy
- not pregnant by self-report and not planning pregnancy
- age > 1 year old
- 21-65 years of age
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- male weight > 130 lbs, female weight > 150 lbs
- male height > 5'1", female height > 5'5"
- hemoglobin > 15.0 g/dL
- reasonably certain of intention to stay in New York City metropolitan area for study duration
- previously tolerated red blood cell donation
Who cannot join
- clinically unstable
- treatment for mental illness
- imprisonment
- institutionalization
- ineligible for donation based on New York Blood Center blood donor screening questionnaire
- systolic blood pressure < 90 or > 180 mm Hg, diastolic blood pressure < 50 or > 100 mm Hg
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- heart rate < 50 or > 100
- temperature > 99.5 F prior to donation
- positive by standard infectious disease testing performed on blood donors
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: Harmful Effects of Transfusion of Older Stored Red Cells: Iron and Inflammation
The purpose of this study is to determine the effects of transfusion of fresh and stored blood on patients.
The investigators hope to test:
- whether a similar effect (older stored blood is associated with worse outcomes) is seen in chronically transfused patients with hemoglobinopathies. This patient population will also allow the investigators to test whether iron- chelation therapy is beneficial in this setting.
- whether washing or cryopreserving the red blood cells has any effect on this outcome.
These findings may explain the immunomodulatory effects of older stored blood in patients and will help us develop safer transfusion products for patients.
Read the detailed description
Epidemiologic studies suggest that older stored blood is associated with worse outcomes in certain hospitalized patients. 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 acute delivery of hemoglobin-iron to the reticuloendothelial system. The investigators have preliminary data in healthy human volunteers suggesting that delivery of a significant iron load to the reticuloendothelial system from aged red cells leads to the elaboration of a potentially toxic form of iron known as non-transferrin-bound iron.
- Conditions
- Sickle Cell Disease, Thalassemia
- Being tested
- Transfusion, Blood, Chelation therapy
- Keywords
- iron, transfusion, red blood cells, sickle cell disease, thalassemia, blood donors
- Medical subject headings
- Anemia, Sickle Cell, Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TransfusionProcedure or surgery
Also called RBC transfusion
A routine medical procedure to transfuse packed red blood cells.
BloodBiological
Also called RBC product, Reb Blood Cells
Processing of RBC for transfusion include the following:
- Fresh
- Stored
- Washed
- Frozen (Cryopreserved)
Chelation therapyProcedure or surgery
(non-experimental) A medical procedure that involves the administration of chelating agents to remove heavy metals from the body.
| Study group | Role | What they receive |
|---|---|---|
| Transfusion of Fresh blood | Active comparator | The recipient will receive one or two units of fresh blood <14 days old, as per their chronic transfusion schedule - on or off chelation therapy. Receives: Procedure: Transfusion; Biological: Blood; Procedure: Chelation therapy |
| Transfusion of Stored blood | Experimental | The recipient will receive one or two units of old blood >28 days old, as per their chronic transfusion schedule - on or off chelation therapy. Receives: Procedure: Transfusion; Biological: Blood; Procedure: Chelation therapy |
| Transfusion of Cryopreserved Blood | Active comparator | The recipient will receive one or two units of cryopreserved (fresh/old) blood, as per their chronic transfusion schedule - off chelation therapy. Receives: Procedure: Transfusion; Biological: Blood |
| Transfusion of Washed Blood | Active comparator | The recipient will receive one or two units of washed (fresh/old) stored blood >28 days old, as per their chronic transfusion schedule - off chelation therapy. Receives: Procedure: Transfusion; Biological: Blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-transferrin-bound Iron Level
Measured: 2 hours after transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Difficulty recruiting donors and recipients, looking for alternative sites
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.
- Other trials for Sickle Cell DiseaseStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 3 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 Spitalnik, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534676
- Sponsor's protocol ID
- AAAI1111
- Other IDs
- R01HL098014
- Status last verified
- Aug 2016
- First submitted
- 14 Feb 2012
- Last updated
- 5 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harmful Effects of Transfusion of Older Stored Red Cells: Iron and Inflammation
- ClinicalTrials.gov ID
- NCT01534676
- Acronym / sponsor ID
- AAAI1111
- Conditions
- Sickle Cell Disease, Thalassemia
- Keywords
- iron, transfusion, red blood cells, sickle cell disease, thalassemia, blood donors
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting donors and recipients, looking for alternative sites
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 17 Feb 2012 (estimated)
- Results
- Posted 5 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effects of transfusion of fresh and stored blood on patients.
The investigators hope to test:
- whether a similar effect (older stored blood is associated with worse outcomes) is seen in chronically transfused patients with hemoglobinopathies. This patient population will also allow the investigators to test whether iron- chelation therapy is beneficial in this setting.
- whether washing or cryopreserving the red blood cells has any effect on this outcome.
These findings may explain the immunomodulatory effects of older stored blood in patients and will help us develop safer transfusion products for patients.
Detailed description
Epidemiologic studies suggest that older stored blood is associated with worse outcomes in certain hospitalized patients. 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 acute delivery of hemoglobin-iron to the reticuloendothelial system. The investigators have preliminary data in healthy human volunteers suggesting that delivery of a significant iron load to the reticuloendothelial system from aged red cells leads to the elaboration of a potentially toxic form of iron known as non-transferrin-bound iron.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Transfusion of Fresh blood | Active comparator | Procedure: Transfusion, Biological: Blood, Procedure: Chelation therapyThe recipient will receive one or two units of fresh blood <14 days old, as per their chronic transfusion schedule - on or off chelation therapy. |
| Transfusion of Stored blood | Experimental | Procedure: Transfusion, Biological: Blood, Procedure: Chelation therapyThe recipient will receive one or two units of old blood >28 days old, as per their chronic transfusion schedule - on or off chelation therapy. |
| Transfusion of Cryopreserved Blood | Active comparator | Procedure: Transfusion, Biological: BloodThe recipient will receive one or two units of cryopreserved (fresh/old) blood, as per their chronic transfusion schedule - off chelation therapy. |
| Transfusion of Washed Blood | Active comparator | Procedure: Transfusion, Biological: BloodThe recipient will receive one or two units of washed (fresh/old) stored blood >28 days old, as per their chronic transfusion schedule - off chelation therapy. |
Who may qualify
- Ages
- 1 year to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- specific, well-characterized hemoglobinopathy
- chronic simple transfusion therapy (transfusion episodes < 6 weeks apart in frequency)
- chronic iron chelation therapy
- not pregnant by self-report and not planning pregnancy
- age > 1 year old
Key exclusion criteria (9 listed)
- clinically unstable
- treatment for mental illness
- imprisonment
- institutionalization
- ineligible for donation based on New York Blood Center blood donor screening questionnaire
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 |
|---|---|---|
| TransfusionAlso: RBC transfusionA routine medical procedure to transfuse packed red blood cells. | Procedure or surgery | Transfusion of Cryopreserved Blood, Transfusion of Fresh blood, Transfusion of Stored blood, Transfusion of Washed Blood |
| BloodAlso: RBC product, Reb Blood CellsProcessing of RBC for transfusion include the following: * Fresh * Stored * Washed * Frozen (Cryopreserved) | Biological | Transfusion of Cryopreserved Blood, Transfusion of Fresh blood, Transfusion of Stored blood, Transfusion of Washed Blood |
| Chelation therapy(non-experimental) A medical procedure that involves the administration of chelating agents to remove heavy metals from the body. | Procedure or surgery | Transfusion of Fresh blood, Transfusion of Stored blood |
Primary outcome
Non-transferrin-bound Iron Level
Time frame: 2 hours after transfusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Steven 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 Transfusion, Blood and Chelation therapy in people with Sickle Cell Disease and Thalassemia, 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 11 inclusion and 9 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: stopped early, as of the sponsor's last update on 5 Oct 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 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 5 Oct 2016). 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 (time frame: 2 hours after transfusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2016.