Healthy VolunteersPhase 2NCT03364686
Transfusion of Biotin-Labeled Red Blood Cells
A Phase 2 study testing Biotin-Labeled Red Blood Cells in people with Healthy Volunteers, run by Gladwin, Mark, MD at 1 site in United States.
Trial summary
The purpose of this research is to evaluate the impact of genetic and biologic factors in blood donors on red blood cell storage stability after autologous transfusion over the different range of storage period of 5-7 days and 35-42 days in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Biotin-Labeled Red Blood Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2019to 29 Jun 2021
- Phase
- Phase 2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 18 years and older
- Weight ≥110 lbs
- Hemoglobin ≥ 12.5 g/dL or hematocrit ≥ 38% for women and hemoglobin ≥ 13.0 g/dL or hematocrit ≥ 39% for men.
- Meet criteria for autologous blood donation
Who cannot join
- Subjects with a past medical history or symptoms of blood dyscrasia, diabetes mellitus, hyperlipidemia, obstructive sleep apnea, renal disease, congestive heart failure, significant cardiac disease and / or known peripheral arterial disease.
- Moderate to severe systemic hypertension (systolic blood pressure >140 mmHg and/or diastolic blood pressure > 95 mmHg
- Systolic blood pressure <100 mmHg and/or diastolic blood pressure < 60 mmHg on the study day.
- Positive Direct Antiglobulin Test
- Consumption of biotin supplements or raw eggs within 30 days
- Treatment with antibiotics in the week before initiating study participation to avoid suppression of erythropoiesis, which may accompany infection.
Show all 16Show fewer
- Blood loss in the previous 8 weeks due to epistaxis, trauma, hemoptysis, gastrointestinal bleeding, diagnostic phlebotomy (> 30 ml)
- Subjects who report tobacco or marijuana smoking within 6 months of study.
- Cognitively impaired subjects, or institutionalized persons and subjects unable or unwilling to complete written informed consent
- Subjects with a history of blood donation within the last 56 days.
- Use of other investigational drugs/devices within 30 days of screening.
- Subjects taking any medication for the treatment of diabetes including insulin
- Females of childbearing potential who are pregnant or unwilling to undergo pregnancy testing; females with positive pregnancy testing on screening day will be excluded.
- History of prior transfusion reaction to blood products.
- Allergic reaction to biotin
- Donors with naturally occurring antibodies against BioRBCs will be excluded from the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Transfusion of Biotin-Labeled Red Blood Cells for the Evaluation of Genetic Factors That Contribute to Donor Differences in Red Blood Cell Storage and Post-Transfusion Red Blood Cell Recovery
The purpose of this research is to evaluate the impact of genetic and biologic factors in blood donors on red blood cell storage stability after autologous transfusion over the different range of storage period of 5-7 days and 35-42 days in healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- Biotin-Labeled Red Blood Cells
- Keywords
- BioRBCs, Biotin labeled red blood cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biotin-Labeled Red Blood CellsBiological
We will collect 500 mL of blood. The blood will be processed and split into two bags and labeled with a naturally occurring vitamin, biotin. The blood will then be re-infused back into the same participant at 2 time points (5-7 days and 35-42 days after storage).
| Study group | Role | What they receive |
|---|---|---|
| Biotin-Labeled Red Blood Cells Infusion | Experimental | Each participant will receive 2 transfusions of biotin labeled red blood cells. Receives: Biological: Biotin-Labeled Red Blood Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Biotin Labeled Red Blood Cells
This will be determined using enumeration of biotinylated red blood cells obtained by flow cytometry from blood samples obtained at various time points from subjects with specified genetic mutations, compared with control subjects without the specified mutation. Percentage of Biotin Labeled Red Blood Cells is determined by Biotin Labeled Red Blood Cells in circulation at each time point/baseline Biotin Labeled Red Blood Cells in circulation x 100.
Measured: 24 hours, 30 days and 60 days after transfusion
Secondary outcomes (3)
The Percentage of Storage Hemolysis
This will be quantified as percent hemolysis, which accounts for the levels of RBC-derived free hemoglobin in response to cold storage. We will define the associations between the primary endpoints and the quantification of storage hemolysis. Quantification of storage hemolysis is based on this equation: (sample hematocrit x levels of free hemoglobin obtained after centrifugation measured in the supernatant / the total amount of sample hemoglobin before centrifugation) x 100.
Measured: 5-7 days and 35-42 days following blood donation
The Percentage of Red Blood Cell Osmotic Hemolysis
This will be quantified by the evaluation of osmotic stress assays. We will define the associations between the primary endpoints and the quantification of osmotic hemolysis. The percent osmotic hemolysis is determined by this equation: (supernatant cell-free hemoglobin of pink test-treated RBCs / total amount of hemoglobin) x 100.
Measured: 5-7 days and 35-42 days following blood donation
The Percentage of Red Blood Cell Oxidative Hemolysis
This will be quantified by the evaluation of oxidative stress assays. We will define the associations between the primary endpoints and the quantification of oxidative hemolysis. The percent osmotic hemolysis is determined by this equation: (supernatant cell-free hemoglobin of 2,2'-azobis-2-methyl-propanimidamide, dihydrochloride treated RBCs - supernatant cell-free hemoglobin of untreated red blood cells / total amount of hemoglobin) x 100.
Measured: 5-7 days and 35-42 days following blood donation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start16 Sep 2019
- Primary completion2 Mar 2021
- Study completion29 Jun 2021
Why it stopped: Due to enrollment challenges related to COVID and lack of coordinator support
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 Healthy VolunteersStudies 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 2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gladwin, Mark, MD
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Darrell Triulzi MD, University of Pittsburgh
- Investigators
- Darrell Triulzi, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364686
- Sponsor's protocol ID
- STUDY19020356
- Other IDs
- 5R01HL098032-09
- Status last verified
- Mar 2022
- First submitted
- 22 Nov 2017
- Last updated
- 21 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfusion of Biotin-Labeled Red Blood Cells for the Evaluation of Genetic Factors That Contribute to Donor Differences in Red Blood Cell Storage and Post-Transfusion Red Blood Cell Recovery
- ClinicalTrials.gov ID
- NCT03364686
- Acronym / sponsor ID
- STUDY19020356
- Conditions
- Healthy Volunteers
- Keywords
- BioRBCs, Biotin labeled red blood cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to enrollment challenges related to COVID and lack of coordinator support
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Gladwin, Mark, MD
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 2 Mar 2021 (actual)
- Study completion
- 29 Jun 2021 (actual)
- First posted
- 6 Dec 2017 (actual)
- Results
- Posted 21 Apr 2022
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 research is to evaluate the impact of genetic and biologic factors in blood donors on red blood cell storage stability after autologous transfusion over the different range of storage period of 5-7 days and 35-42 days in healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biotin-Labeled Red Blood Cells Infusion | Experimental | Biological: Biotin-Labeled Red Blood CellsEach participant will receive 2 transfusions of biotin labeled red blood cells. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages 18 years and older
- Weight ≥110 lbs
- Hemoglobin ≥ 12.5 g/dL or hematocrit ≥ 38% for women and hemoglobin ≥ 13.0 g/dL or hematocrit ≥ 39% for men.
- Meet criteria for autologous blood donation
Key exclusion criteria (16 listed)
- Subjects with a past medical history or symptoms of blood dyscrasia, diabetes mellitus, hyperlipidemia, obstructive sleep apnea, renal disease, congestive heart failure, significant cardiac disease and / or known peripheral arterial disease.
- Moderate to severe systemic hypertension (systolic blood pressure >140 mmHg and/or diastolic blood pressure > 95 mmHg
- Systolic blood pressure <100 mmHg and/or diastolic blood pressure < 60 mmHg on the study day.
- Positive Direct Antiglobulin Test
- Consumption of biotin supplements or raw eggs within 30 days
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 |
|---|---|---|
| Biotin-Labeled Red Blood CellsWe will collect 500 mL of blood. The blood will be processed and split into two bags and labeled with a naturally occurring vitamin, biotin. The blood will then be re-infused back into the same participant at 2 time points (5-7 days and 35-42 days after storage). | Biological | Biotin-Labeled Red Blood Cells Infusion |
Primary outcome
Percentage of Biotin Labeled Red Blood Cells
Time frame: 24 hours, 30 days and 60 days after transfusion
This will be determined using enumeration of biotinylated red blood cells obtained by flow cytometry from blood samples obtained at various time points from subjects with specified genetic mutations, compared with control subjects without the specified mutation. Percentage of Biotin Labeled Red Blood Cells is determined by Biotin Labeled Red Blood Cells in circulation at each time point/baseline Biotin Labeled Red Blood Cells in circulation x 100.
3 secondary outcomes
The Percentage of Storage Hemolysis
Time frame: 5-7 days and 35-42 days following blood donation
The Percentage of Red Blood Cell Osmotic Hemolysis
Time frame: 5-7 days and 35-42 days following blood donation
The Percentage of Red Blood Cell Oxidative Hemolysis
Time frame: 5-7 days and 35-42 days following blood donation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Darrell Triulzi, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biotin-Labeled Red Blood Cells in people with Healthy Volunteers, run by Gladwin, Mark, MD 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 16 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 21 Apr 2022. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2022). 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?
Percentage of Biotin Labeled Red Blood Cells (time frame: 24 hours, 30 days and 60 days 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 21 Apr 2022.