An interventional study of Red Blood Cell Transfusions (RBCT) in Anemia, Aplastic Anemia and Bone Marrow Failure, sponsored by Emory University. Withdrawn at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2018-07-26.
Sponsored by Emory University · Not applicable, Interventional, and Supportive care
Among 171 studies in Anemia, Aplastic with a site in United States — 28 open to participants now, 41 under way, none of them phase 3. Anemia, Aplastic · United States.
Among the 171 studies in Anemia, Aplastic with a site in United States, this one is the 138th largest by enrollment of the 139 interventional ones that give a count, is one of 8 that started in 2017, is one of 23 with no phase, and was the 125th registered.
371 studies on the registry are indexed under Anemia, Aplastic; 98 are open to participants now.
Browse Anemia, Aplastic studies →28 of the 171 studies in Anemia, Aplastic with a site in United States are open now. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States
Dren Bio · Sites in United States
Medical College of Wisconsin · Sites in United States
Medical College of Wisconsin · Sites in United States
Washington University School of Medicine · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 58 Anemia, Aplastic studies recruiting now, 20 (34%) set no upper age limit and 30 (52%) stop at 75 or younger; 37 take children under 18; 5 take healthy volunteers.
This study: 19 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
171 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 40 · Phase 2 98 · Phase 3 5 · Phase 4 1
First in 1986; this study’s year is marked. 8 started in 2017.
Median enrollment 31 across the 139 interventional studies, 50 across the 27 observational. Of the 122 that completed or were terminated, 59 (48%) have results posted.
This tab as a report to print or save as PDF → With an account.
14 of 171 have an industry lead sponsor. The 10 most frequent:
Emory University is the lead sponsor of 1,405 studies on the registry; 225 are open to participants now.
Of its 237 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.
Emory University has 4 studies filed under Anemia, Aplastic — fewer than ten, so there is no comparison to draw.
13 of the studies in Anemia, Aplastic with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06689800Washington University School of MedicineLet's Get REAL: Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular Therapy | 2026-11-30 |
| NCT01659606Boston Children's HospitalRadiation- and Alkylator-free Bone Marrow Transplantation Regimen for Patients With Dyskeratosis Congenita | 2026-12 |
| NCT04099966Mitchell CairoAlloSCT for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion | 2026-12-31 |
| NCT03579875Masonic Cancer Center, University of MinnesotaAlpha/Beta TCD HCT in Patients With Inherited BMF Disorders | 2027-01-01 |
| NCT03924401Emory UniversityAcute GVHD Suppression Using Costimulation Blockade to Expand Non-malignant Transplant | 2027-03-01 |
Among the 171 studies in Anemia, Aplastic with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This pilot study evaluates safety of administration of red blood cell transfusions requested by patients based on their symptoms instead of levels of hemoglobin for the treatment of chronic anemia in patients with blood disorders.
PRIMARY OBJECTIVE:
I. To assess feasibility and safety of red blood cell transfusions at the time subjects requested based on symptomatic anemia.
SECONDARY OBJECTIVES:
I. To define a patient-driven red blood cell transfusion (RBCT) threshold and to compare the median hemoglobin (hgb) at the time subjects request RBCT to the standard threshold of hgb \< 8 g/dL.
II. To compare the number of red blood cell (RBC) units transfused and the frequency of transfusions at the time subjects request RBCT during the study period to the number of RBC units received and frequency using the standard threshold hemoglobin \< 8 g/dL during a comparable period prior to enrollment.
III. To compare the quality of life (QoL) scores when subjects request RBCT to the scores obtained at the time hgb is 8 +/- 0.5 g/dL.
OUTLINE:
Patients undergo RBCT based on their perception and/or the presence of anemia symptoms for up to 6 months.
After completion of study treatment, patients are followed up for 30 days.
371 studies on the registry are indexed under Anemia, Aplastic; 98 are open to participants now.
Browse Anemia, Aplastic studies →Emory University is the lead sponsor of 1,405 studies on the registry; 225 are open to participants now.
Of its 237 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.
Compared within Anemia, Aplastic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anemia. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergo red blood cell transfusions (RBCT) based on their perception and/or the presence of anemia symptoms for up to 6 months.
Procedure: Red Blood Cell Transfusions (RBCT)
Undergo patient-driven RBCT
Also known as: Blood Component Transfusion, Blood Transfusion, Transfusion, Transfusion of Blood Products
Incidence of laboratory and clinical adverse events (AEs) assessed by the Common Terminology Criteria for Adverse Events version 4.03.
Frequency, duration, and severity of AEs and severe adverse events will be determined. The proportion of subjects with serious side effects will be calculated with 95% confidence interval. Descriptive statistics will be used to characterize subjects enrolled on the trial: age, sex, race and diagnosis.
Time frame: Up to 6 months of study participation
Frequency of RBC units transfused
The frequency of RBC units transfused will be compared between study period and prior to enrollment for the same patient (e.g. each patient will serve his/her own control) by Wilcoxon's sign rank test.
Time frame: Up to 6 months of study participation
Hemoglobin concentration at the time subject requests RBCT
Hemoglobin concentration (Hgb) will be measured in g/dL.
Time frame: Up to 6 months of study participation
Number of RBC units transfused
The number of RBC units transfused will be compared between study period and prior to enrollment for the same patient (e.g. each patient will serve his/her own control) by Wilcoxon's sign rank test.
Time frame: Up to 6 months of study participation
QoL scores from the Functional Assessment of Cancer Therapy - Anemia/Fatigue (FACT-An) questionnaire at the time hemoglobin is 8 +/- 0.5 g/dL
Will be compared to QoL scores at the time subjects request RBCT by paired t-test and/or Wilcoxon sign rank test.
Time frame: Up to 6 months of study participation
QoL scores from the Functional Assessment of Cancer Therapy - Anemia/Fatigue (FACT-An) questionnaire at the time subjects request RBCT
Will be compared to QoL scores at the time hgb is 8 +/- 0.5 g/dL by paired t-test and/or Wilcoxon sign rank test.
Time frame: Up to 6 months of study participation
Ran from Jul 2017 to primary completion in May 2018, 10 months.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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