Transfusion ReactionPhase 1Pooled RBCsNCT03056378

POOLED Red Blood Cells Prepared From Pooling 5 Leukoreduced, Irradiated RBC Units

A Phase 1 study testing Standard RBCs in people with Transfusion Reaction and Anemia, run by New York Blood Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Transfusion Reaction, Anemia
What is being tested?: Standard RBCs
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited States
Study dates: Oct 2019to Jun 2021
Phase: Phase 1
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 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age>= 18 years
Hematology/ oncology or other chronic transfusion dependent patients
Patients who are in need of transfusion due to low hemoglobin level (<8 gm/dl)
Patients who only require one or two transfusion episode of 1-2 RBC units each during 60 day period
Currently not planning to be pregnant during the study period

Who cannot join

Previously identified alloantibodies (other than to D, C, E and K)
Positive direct antiglobulin test, currently or within the last year
Emergency transfusion
Patients < 18 years old
Need for specialized products, such as washed
Patients involved in other RBC transfusion clinical trial
Currently or planning to be pregnant within the proposed study period

Trial locations and contacts

1 site in 1 country.

United States1 site

Westchester Medical Center/New York Medical College
Valhalla, New York, 10595

Other trials in United States

About this study

Official title: Phase I Clinical Trial of Pooled Red Blood Cells for Transfusion

The purpose of the study is to determine the safety of pooled red blood cells (RBCs) compared to standard leukoreduced RBC products stored in additive solution. The primary objective is to determine if there is no significant difference in transfusion associated adverse events in POOLED-RBCs compared to standard RBC product groups. Secondarily to determine if there are no significant differences in new antibody and new positive direct antiglobulin test (DAT) formation in the POOLED-RBCs compared to standard RBC product groups.

Read the detailed description

This research study is enrolling subjects who are receiving RBC (red blood cell) blood transfusions as part of their treatment. In this study, we are testing a new way of preparing RBC units (pooled RBC units) for transfusion compared to the standard RBC units. We are testing this because blood transfusions may be associated with side effects that may be harmful. We have developed a new way to process RBC for transfusion to try and reduce some of those side effects.

The pooled RBC units will be made by sterilely pooling five (5) single RBC units into one container where the blood will be mixed together, and then separated into five individual RBC units, ready to be used for transfusion. The purpose of the study is to determine the safety of the blood prepared in this new way compared to standard RBC products.

The primary objective is to determine if there is no significant difference in transfusion associated adverse events in POOLED-RBCs compared to standard RBC product groups. Secondarily to determine if there are no significant differences in new antibody and new positive direct antiglobulin test (DAT) formation in the POOLED-RBCs compared to standard RBC product groups.

Conditions: Transfusion Reaction, Anemia
Being tested: Standard RBCs
Medical subject headings: Transfusion Reaction, Anemia

What participants receive

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

Standard RBCsBiological
Transfusion of standard pRBCs that are matched for C, E and K

Study groups in NCT03056378
Study group	Role	What they receive
Pooled RBCs	Experimental	Transfusion of an investigational transfusion blood component: POOLED-RBCs Phenotype matched/ compatible for ABO, D, C, E, and K (blood type of pool will be match patient's type), leukoreduced, and irradiated Receives: Biological: Standard RBCs
Standard RBCs	Active comparator	Transfusion of standard transfusion blood component: additive solution leukoreduced, irradiated RBC product Phenotype matched/ compatible for ABO, D, C, E, and K (blood type of pool will be match patient's type) Receives: Biological: Standard RBCs

What is being measured

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

Quantitation of adverse events
Measured: 60 day endpoint

Secondary outcomes (1)

Quantitation of RBC alloantibody formation
Quantitation of new DAT formation
Measured: 15 and 30 minutes post-transfusion

Timeline

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

Oct 2019Jun 2021

First posted17 Feb 2017
Study startOct 2019 (estimated)
Primary completionDec 2020 (estimated)
Study completionJun 2021 (estimated)

Why it stopped: No patients enrolled. Study withdrawn.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Transfusion ReactionStudies of the same condition, open and under way.
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 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03056378
Sponsor's protocol ID: NYBC-0088
Acronym: Pooled RBCs
Status last verified: Dec 2019
First submitted: 13 Jan 2017
Last updated: 26 Dec 2019
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Hendrickson JE, Hillyer CD. Noninfectious serious hazards of transfusion. Anesth Analg. 2009 Mar;108(3):759-69. doi: 10.1213/ane.0b013e3181930a6e.
PubMed 19224780
Tobian AA, Fuller AK, Uglik K, Tisch DJ, Borge PD, Benjamin RJ, Ness PM, King KE. The impact of platelet additive solution apheresis platelets on allergic transfusion reactions and corrected count increment (CME). Transfusion. 2014 Jun;54(6):1523-9; quiz 1522. doi: 10.1111/trf.12498. Epub 2013 Nov 19.
PubMed 24251374
Hess JR; Biomedical Excellence for Safer Transfusion (BEST) Collaborative. Scientific problems in the regulation of red blood cell products. Transfusion. 2012 Aug;52(8):1827-35. doi: 10.1111/j.1537-2995.2011.03511.x. Epub 2012 Jan 9.
PubMed 22229278
Marthur A, Stassinopoulos A, Hess JR, Narla M, Shaz BH. Effects of pooling multiple red blood cell units to improve storage. Blood 2012;120:3437
Mathur A, Chowdhury R, Hillyer CD, Mitchell WB, Shaz BH. Storage characteristics of multiple-donor pooled red blood cells compared to single-donor red blood cell units. Transfusion. 2016 Dec;56(12):2941-2947. doi: 10.1111/trf.13866. Epub 2016 Oct 5.
PubMed 27704557
Lasalle-Williams M, Nuss R, Le T, Cole L, Hassell K, Murphy JR, Ambruso DR. Extended red blood cell antigen matching for transfusions in sickle cell disease: a review of a 14-year experience from a single center (CME). Transfusion. 2011 Aug;51(8):1732-9. doi: 10.1111/j.1537-2995.2010.03045.x. Epub 2011 Feb 18.
PubMed 21332724
Verduin EP, Brand A, Schonewille H. Is female sex a risk factor for red blood cell alloimmunization after transfusion? A systematic review. Transfus Med Rev. 2012 Oct;26(4):342-53, 353.e1-5. doi: 10.1016/j.tmrv.2011.12.001. Epub 2012 Jan 13.
PubMed 22244869
Custer B, Agapova M, Martinez RH. The cost-effectiveness of pathogen reduction technology as assessed using a multiple risk reduction model. Transfusion. 2010 Nov;50(11):2461-73. doi: 10.1111/j.1537-2995.2010.02704.x.
PubMed 20497512
Sweeney JD, Kouttab NM, Holme S, Kurtis JD, Cheves TA, Nelson EJ. Prestorage pooled whole-blood-derived leukoreduced platelets stored for seven days, preserve acceptable quality and do not show evidence of a mixed lymphocyte reaction. Transfusion. 2004 Aug;44(8):1212-9. doi: 10.1111/j.1537-2995.2004.03438.x.
PubMed 15265126
Thiele T, Heddle N, Greinacher A. Donor exposures in recipients of pooled platelet concentrates. N Engl J Med. 2013 Jan 31;368(5):487-9. doi: 10.1056/NEJMc1213383. No abstract available.
PubMed 23363522
Zou S, Stramer SL, Dodd RY. Donor testing and risk: current prevalence, incidence, and residual risk of transfusion-transmissible agents in US allogeneic donations. Transfus Med Rev. 2012 Apr;26(2):119-28. doi: 10.1016/j.tmrv.2011.07.007. Epub 2011 Aug 25.
PubMed 21871776
Stramer SL, Notari EP, Krysztof DE, Dodd RY. Hepatitis B virus testing by minipool nucleic acid testing: does it improve blood safety? Transfusion. 2013 Oct;53(10 Pt 2):2449-58. doi: 10.1111/trf.12213. Epub 2013 Apr 23.
PubMed 23607261
Levin AE, Williamson PC, Bloch EM, Clifford J, Cyrus S, Shaz BH, Kessler D, Gorlin J, Erwin JL, Krueger NX, Williams GV, Penezina O, Telford SR 4th, Branda JA, Krause PJ, Wormser GP, Schotthoefer AM, Fritsche TR, Busch MP. Serologic screening of United States blood donors for Babesia microti using an investigational enzyme immunoassay. Transfusion. 2016 Jul;56(7):1866-74. doi: 10.1111/trf.13618. Epub 2016 May 25.
PubMed 27224258
Levin AE, Williamson PC, Erwin JL, Cyrus S, Bloch EM, Shaz BH, Kessler D, Telford SR 3rd, Krause PJ, Wormser GP, Ni X, Wang H, Krueger NX, Caglioti S, Busch MP. Determination of Babesia microti seroprevalence in blood donor populations using an investigational enzyme immunoassay. Transfusion. 2014 Sep;54(9):2237-44. doi: 10.1111/trf.12763. Epub 2014 Jul 4.
PubMed 24995863
Tormey CA, Sweeney JD, Champion MH, Pisciotto PT, Snyder EL, Wu Y. Analysis of transfusion reactions associated with prestorage-pooled platelet components. Transfusion. 2009 Jun;49(6):1242-7. doi: 10.1111/j.1537-2995.2009.02128.x. Epub 2009 Mar 23.
PubMed 19389029

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Transfusion Reaction trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Clinical Trial of Pooled Red Blood Cells for Transfusion
ClinicalTrials.gov ID: NCT03056378
Acronym / sponsor ID: Pooled RBCs / NYBC-0088
Conditions: Transfusion Reaction, Anemia
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: No patients enrolled. Study withdrawn.
Enrolment: 0 participants (actual)
Lead sponsor: New York Blood CenterUniversity, hospital or other
Collaborators: Westchester Medical Center
Study start: Oct 2019 (estimated)
Primary completion: Dec 2020 (estimated)
Study completion: Jun 2021 (estimated)
First posted: 17 Feb 2017 (actual)
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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Pooled RBCs	Experimental	Biological: Standard RBCsTransfusion of an investigational transfusion blood component: POOLED-RBCs Phenotype matched/ compatible for ABO, D, C, E, and K (blood type of pool will be match patient's type), leukoreduced, and irradiated
Standard RBCs	Active comparator	Biological: Standard RBCsTransfusion of standard transfusion blood component: additive solution leukoreduced, irradiated RBC product Phenotype matched/ compatible for ABO, D, C, E, and K (blood type of pool will be match patient's type)

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age>= 18 years
Hematology/ oncology or other chronic transfusion dependent patients
Patients who are in need of transfusion due to low hemoglobin level (<8 gm/dl)
Patients who only require one or two transfusion episode of 1-2 RBC units each during 60 day period
Currently not planning to be pregnant during the study period

Key exclusion criteria (7 listed)

Previously identified alloantibodies (other than to D, C, E and K)
Positive direct antiglobulin test, currently or within the last year
Emergency transfusion
Patients < 18 years old
Need for specialized products, such as washed

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
Standard RBCsTransfusion of standard pRBCs that are matched for C, E and K	Biological	Pooled RBCs, Standard RBCs

Primary outcome

Quantitation of adverse events
Time frame: 60 day endpoint

1 secondary outcome

Quantitation of RBC alloantibody formation
Time frame: 15 and 30 minutes post-transfusion

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
Background: PubMed 19224780Hendrickson JE, Hillyer CD. Noninfectious serious hazards of transfusion. Anesth Analg. 2009 Mar;108(3):759-69. doi: 10.1213/ane.0b013e3181930a6e.
Background: PubMed 24251374Tobian AA, Fuller AK, Uglik K, Tisch DJ, Borge PD, Benjamin RJ, Ness PM, King KE. The impact of platelet additive solution apheresis platelets on allergic transfusion reactions and corrected count increment (CME). Transfusion. 2014 Jun;54(6):1523-9; quiz 1522. doi: 10.1111/trf.12498. Epub 2013 Nov 19.
Background: PubMed 22229278Hess JR; Biomedical Excellence for Safer Transfusion (BEST) Collaborative. Scientific problems in the regulation of red blood cell products. Transfusion. 2012 Aug;52(8):1827-35. doi: 10.1111/j.1537-2995.2011.03511.x. Epub 2012 Jan 9.
BackgroundMarthur A, Stassinopoulos A, Hess JR, Narla M, Shaz BH. Effects of pooling multiple red blood cell units to improve storage. Blood 2012;120:3437
Background: PubMed 27704557Mathur A, Chowdhury R, Hillyer CD, Mitchell WB, Shaz BH. Storage characteristics of multiple-donor pooled red blood cells compared to single-donor red blood cell units. Transfusion. 2016 Dec;56(12):2941-2947. doi: 10.1111/trf.13866. Epub 2016 Oct 5.
Background: PubMed 21332724Lasalle-Williams M, Nuss R, Le T, Cole L, Hassell K, Murphy JR, Ambruso DR. Extended red blood cell antigen matching for transfusions in sickle cell disease: a review of a 14-year experience from a single center (CME). Transfusion. 2011 Aug;51(8):1732-9. doi: 10.1111/j.1537-2995.2010.03045.x. Epub 2011 Feb 18.
Background: PubMed 22244869Verduin EP, Brand A, Schonewille H. Is female sex a risk factor for red blood cell alloimmunization after transfusion? A systematic review. Transfus Med Rev. 2012 Oct;26(4):342-53, 353.e1-5. doi: 10.1016/j.tmrv.2011.12.001. Epub 2012 Jan 13.
Background: PubMed 20497512Custer B, Agapova M, Martinez RH. The cost-effectiveness of pathogen reduction technology as assessed using a multiple risk reduction model. Transfusion. 2010 Nov;50(11):2461-73. doi: 10.1111/j.1537-2995.2010.02704.x.
Background: PubMed 15265126Sweeney JD, Kouttab NM, Holme S, Kurtis JD, Cheves TA, Nelson EJ. Prestorage pooled whole-blood-derived leukoreduced platelets stored for seven days, preserve acceptable quality and do not show evidence of a mixed lymphocyte reaction. Transfusion. 2004 Aug;44(8):1212-9. doi: 10.1111/j.1537-2995.2004.03438.x.
Background: PubMed 23363522Thiele T, Heddle N, Greinacher A. Donor exposures in recipients of pooled platelet concentrates. N Engl J Med. 2013 Jan 31;368(5):487-9. doi: 10.1056/NEJMc1213383. No abstract available.
Background: PubMed 21871776Zou S, Stramer SL, Dodd RY. Donor testing and risk: current prevalence, incidence, and residual risk of transfusion-transmissible agents in US allogeneic donations. Transfus Med Rev. 2012 Apr;26(2):119-28. doi: 10.1016/j.tmrv.2011.07.007. Epub 2011 Aug 25.
Background: PubMed 23607261Stramer SL, Notari EP, Krysztof DE, Dodd RY. Hepatitis B virus testing by minipool nucleic acid testing: does it improve blood safety? Transfusion. 2013 Oct;53(10 Pt 2):2449-58. doi: 10.1111/trf.12213. Epub 2013 Apr 23.

Related trials for Transfusion Reaction

Active, not recruitingObservational study
Mechanisms of Anaphylaxis
Anaphylaxis, Allergy
Not yet recruitingPhase 2
Challenge Transfusion of INTERCEPT Pathogen Reduced Red Blood Cells (RBCs) in Subjects With or Without Pre-existing Antibodies to INTERCEPT RBCs
Transfusion Reaction, Hemolytic
RecruitingPhase 4
Antihistamine for Prevention of HTR After Blood Primed CPB
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Not yet recruitingObservational study
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RecruitingObservational study
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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.

Beth Shaz, M.D. principal investigator

New York Blood Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Standard RBCs in people with Transfusion Reaction and Anemia, run by New York Blood Center 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 5 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: withdrawn, as of the sponsor's last update on 26 Dec 2019. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 was withdrawn before enrolling participants, so there are no results.

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?

Quantitation of adverse events (time frame: 60 day endpoint). 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 NCT03056378, which also lists 16 linked publications.

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 26 Dec 2019; AzTrials last refreshed its copy on 6 Nov 2026.