Erythrocyte TransfusionPhase 4NCT03089047
Rejuvenated RBC and VO2 Max in Healthy Subjects
A Phase 4 study testing Transfusion of rejuvenated and washed autolgous RBCs and Transfusion of washed autolgous RBCs in people with Erythrocyte Transfusion, run by Duke University at 1 site in United States.
Trial summary
To compare the physiologic benefits of rejuvenated RBCs (rejRBCs) to standards RBCs (PRBCs), we will emulate critical conditions by safely maximizing stress on the cardiovascular system, in an elective, feasible volunteer study. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Erythrocyte Transfusion
- What is being tested?
- Transfusion of rejuvenated and washed autolgous RBCs and Transfusion of washed autolgous RBCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2017to 18 Apr 2018
- Phase
- Phase 4
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female
- Age 18-40 (the American College of Sports Medicine Guidelines for Exercise Testing defines this age group with no or no more than one coronary heart disease risk factor as low-risk for VO2 max testing)
- Habitual exerciser defined as ≥ 30 minutes of at least moderate or high intensity exercise ≥ 3 times per week. After consent, and at the subsequent screening visit, a VO2 max test will be performed, and subjects with a low value (< 35 mL/kg/min) will be excluded (screen failure). Based on our previous experience, we anticipate that up to 25% of the subjects will fall into this category; therefore, 10 subjects will be screened to obtain 6-8 participants who go on to donate their blood.
- Calculated total blood volume of at least 4,500 mL using an established formula:
- Men: (0.006012 x H3) + (14.6 x W) + 604 = TBV
- Women: (0.005835 x H3) + (15 x W) + 183 = TBV [H= Height in inches; W=Weight in pounds]
- Has access to transportation to visit the blood collection facility and to return to Duke for all study visits
- Weighs at least 130 pounds
Who cannot join
- Any significant acute or chronic medical illness or problem, including, but not limited to, diabetes, hypertension, cardiac disease, asthma, COPD
- Current or recent (last 60 days) tobacco or nicotine use
- History of sickle cell trait or disease or any other acquired or hereditary hematological abnormality
- History of fainting or other significant adverse reaction during phlebotomy or donation of blood
- Known prolonged QTc (or evidence of such at screening) defined as QTc >470 ms
- Known or suspected illicit drug or alcohol abuse
Show all 16Show fewer
- Known or suspected HIV, Hepatitis B, or Hepatitis C infection
- History of thrombophilia or anticoagulant therapy
- Pregnancy
- Obesity defined as BMI>30
- Recent history of blood donation:
- Single whole blood unit donation within the past 8 weeks
- Double RBC donation by apheresis within the past 16 weeks
- Plasma donation by apheresis within the past 4 weeks
- Inadequate red blood cell mass evidenced by total blood volume <4500 mL (above) or screening hemoglobin <13.3 g/dL
- Known hypersensitivity to lithium compounds.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27514
About this study
Official title: A Pilot Study on the Impact of Rejuvenated Autologous Blood Transfusion on VO2 Max in Healthy Subjects
To compare the physiologic benefits of rejuvenated RBCs (rejRBCs) to standards RBCs (PRBCs), we will emulate critical conditions by safely maximizing stress on the cardiovascular system, in an elective, feasible volunteer study. Maximal oxygen uptake (VO2max) will be measured in an anemic, post-donation, pre-transfusion state, and also after transfusing 14-day-old, autologous blood randomized to standard storage or standard storage with rejuvenation. We hypothesize that transfusion of standard PRBCs is less effective at increasing oxygen delivery (measured by VO2max) compared with transfusion of rejRBCs.
Read the detailed description
VISIT A ( - Screening) Written informed consent will be obtained from subjects who respond to an IRB-approved advertisement/flyer and fulfill eligibility requirements. The following video will help explain the study: vimeo.com/167291799. Individuals who respond to an IRB approved advertisement/flyer (uploaded to eIRB) will be given information about the study and asked to read an IRB approved consent form. An investigator or designee will obtain written informed consent from each individual participating in this study, after adequate explanation of the methods, objectives, and potential hazards of the study. The investigator or designee will also explain to the subjects that they are completely free to refuse to enter the study and free to withdraw from it at any time. A copy of the signed consent form will be given to the subject and will be shared with The Blood Connection to ensure proper labeling of autologous units.
After subjects have provided written informed consent, they will be asked to answer several questions in 2 written questionnaires (uploaded to eIRB) in order to confirm that they are eligible to donate blood. These questions are similar to those routinely asked to people prior to a blood donation. These are focused upon keeping the risks of blood donation to the lowest possible level. Subject will undergo screening lab tests for baseline hemoglobin, sickle cell trait, serum pregnancy tests only for women of child-bearing potential, ECG, exercise test. Subject will receive a phone confirmation from the investigator or delegated research staff after review of the screening lab results. Subject will bring a copy of the signed consent form to The Blood Connection if qualified.
VISIT B (Day 0 - Blood donation) The Blood Connection (TBC), Raleigh, NC, is registered and licensed by the US FDA and accredited by the American Association of Blood Banks (AABB) to manufacture RBCs and other blood products. Two units of blood will be withdrawn from each subject according to standards for double, AS-3, apheresis units, and will be marked for autologous donation, and purchased by Duke Transfusion Services, as arranged with the medical director of TBC (Robert Rainer, MD). RBC handling and storage will meet FDA and AABB standards; units will be stored with Duke Transfusion Services c/o Dr. Poisson.
VISIT C (Day 14 - "Anemic" VO2 max, Transfusion (Tx) and "post-Tx" VO2max)) Small amount of blood [3 lavender topped tubes] will be collected from subject to test for hemoglobin, type \& screen and 1 cross match to verify the donated blood received from The Blood Connection belongs to the same subject who arrives at the appointed date at Duke facility
Anemic VO2max Three minutes of resting baseline measures will be recorded before the start of exercise. The subject will then begin to pedal the cycle ergometer at a cadence of 75 rpm. Resistance will be manually set according to a standardized, progressive protocol. A rating of perceived exertion (RPE) will be obtained at the end of each exercise stage. Vital signs will be recorded every 3 minutes, and ECG monitoring will be continuous. Exercise will be terminated when the subject reaches volitional fatigue. VO2max will be reported as the highest oxygen consumption averaged over two 30-second periods, which typically occurs in the last stage of the progressive maximal exercise test. Maximum heart rate will be the heart rate at or near VO2max. To minimize variability in VO2max testing procedures, the same 2 facilitators (an engineer/technician and a research staff) will be present at every test. Radial arterial access will be obtained for cardiac output monitoring (LiDCO pulse contour analysis) at this visit.
Tx and post-Tx VO2max Duke Transfusion Services will randomize each subject to receive 2 units of standard PRBCs or rejRBCs over 120 minutes using a standard infusion pump. All units will be washed to equalize the transfusion volumes; rejuvenation includes a mandatory washing step. Rejuvenation of donated blood will be done according to the procedures in the labeling of the Rejuvesol product. Vital signs will be monitored and recorded every 15 minutes. After a total 4-hour rest after completing the first VO2max testing, and a light snack, the exercise test will be repeated.
Laboratory testing: The p50 will be measured in one of the blood units transfused and in the subject before the exercise test. Radial arterial access will be obtained for serial cardiac output monitoring (LiDCO Pulse Contour Analysis, LiDCO Products, London, UK), arterial blood gas analysis and lactate measurement before and after transfusion, and after exercise testing. Final blood collected for a hemoglobin level will be done at the conclusion of blood transfusion. This is the final visit and participation is completed.
- Conditions
- Erythrocyte Transfusion
- Being tested
- Transfusion of rejuvenated and washed autolgous RBCs, Transfusion of washed autolgous RBCs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transfusion of rejuvenated and washed autolgous RBCsBiological
Rejuvenation refers to the process of adding a mix of solutes (Rejuvesol®, Citra Labs, Braintree, MA; consists of sodium pyruvate, inosine, adenine, mono- and dibasic sodium phosphate) to older, stored (i.e., 2-3 DPG-depleted) blood to immediately restore 2,3-DPG and ATP levels in the stored red blood cells15. Rejuvenation was originally developed to prolong the storage life of rare-phenotype RBC units. It is FDA-approved for use in RBC units stored in CPD, CPDA-1, and AS-1. The major contraindication for the use of Rejuvesol® is in RBC units stored for fewer than 6 days due to high baseline 2,3-DPG and ATP levels. Rejuvenated units must be washed prior to administration to remove residual Rejuvesol that is not approved for iv administration in such concentrations.
Transfusion of washed autolgous RBCsBiological
Autologous RBCs will be washed prior to transfusion to maintain blinding and equalize volume and Hct with the rejuvenated and washed intervention arm
| Study group | Role | What they receive |
|---|---|---|
| Rejuvenated RBC Transfusion | Experimental | Washed and Rejuvenated autologous blood Receives: Biological: Transfusion of rejuvenated and washed autolgous RBCs |
| Standard RBC Transfusion | Sham comparator | Washed autologous blood (so as to maintain equivalent unit volume and Hct) Receives: Biological: Transfusion of washed autolgous RBCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VO2max
Change in VO2max from "anemic" (pre-transfusion) VO2max and after transfusion of 2 units of either standard PRBCs or rej-PRBCs "post-Tx" VO2max.
Measured: Day 16 to Day 18 post transfusion
Change in Lactate
Change in lactate from "anemic" (pre-transfusion) VO2max and after transfusion of 2 units of either standard PRBCs or rej-PRBCs "post-Tx" VO2max
Measured: Day 16 to Day 18 post transfusion
Secondary outcomes (1)
Change in "Post-Tx" VO2max From Baseline
Change in "post-Tx" (after transfusion) VO2max at day 18 from baseline.
Measured: Baseline to Day 18 post transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start29 Sep 2017
- Primary completion18 Apr 2018
- Study completion18 Apr 2018
Why it stopped: Reagent shortage
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 Erythrocyte TransfusionStudies of the same condition, open and under way.
- More trials run by Duke 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized "healthy volunteer" study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Sponsor
- Investigators
- Ian J Welsby, BSc MBBS, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089047
- Sponsor's protocol ID
- Pro00078468
- Status last verified
- Dec 2020
- First submitted
- 20 Mar 2017
- Last updated
- 11 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Impact of Rejuvenated Autologous Blood Transfusion on VO2 Max in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03089047
- Acronym / sponsor ID
- Pro00078468
- Conditions
- Erythrocyte Transfusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Reagent shortage
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 18 Apr 2018 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 24 Mar 2017 (actual)
- Results
- Posted 11 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the physiologic benefits of rejuvenated RBCs (rejRBCs) to standards RBCs (PRBCs), we will emulate critical conditions by safely maximizing stress on the cardiovascular system, in an elective, feasible volunteer study. Maximal oxygen uptake (VO2max) will be measured in an anemic, post-donation, pre-transfusion state, and also after transfusing 14-day-old, autologous blood randomized to standard storage or standard storage with rejuvenation. We hypothesize that transfusion of standard PRBCs is less effective at increasing oxygen delivery (measured by VO2max) compared with transfusion of rejRBCs.
Detailed description
VISIT A ( - Screening) Written informed consent will be obtained from subjects who respond to an IRB-approved advertisement/flyer and fulfill eligibility requirements. The following video will help explain the study: vimeo.com/167291799. Individuals who respond to an IRB approved advertisement/flyer (uploaded to eIRB) will be given information about the study and asked to read an IRB approved consent form. An investigator or designee will obtain written informed consent from each individual participating in this study, after adequate explanation of the methods, objectives, and potential hazards of the study. The investigator or designee will also explain to the subjects that they are completely free to refuse to enter the study and free to withdraw from it at any time. A copy of the signed consent form will be given to the subject and will be shared with The Blood Connection to ensure proper labeling of autologous units.
After subjects have provided written informed consent, they will be asked to answer several questions in 2 written questionnaires (uploaded to eIRB) in order to confirm that they are eligible to donate blood. These questions are similar to those routinely asked to people prior to a blood donation. These are focused upon keeping the risks of blood donation to the lowest possible level. Subject will undergo screening lab tests for baseline hemoglobin, sickle cell trait, serum pregnancy tests only for women of child-bearing potential, ECG, exercise test. Subject will receive a phone confirmation from the investigator or delegated research staff after review of the screening lab results. Subject will bring a copy of the signed consent form to The Blood Connection if qualified.
VISIT B (Day 0 - Blood donation) The Blood Connection (TBC), Raleigh, NC, is registered and licensed by the US FDA and accredited by the American Association of Blood Banks (AABB) to manufacture RBCs and other blood products. Two units of blood will be withdrawn from each subject according to standards for double, AS-3, apheresis units, and will be marked for autologous donation, and purchased by Duke Transfusion Services, as arranged with the medical director of TBC (Robert Rainer, MD). RBC handling and storage will meet FDA and AABB standards; units will be stored with Duke Transfusion Services c/o Dr. Poisson.
VISIT C (Day 14 - "Anemic" VO2 max, Transfusion (Tx) and "post-Tx" VO2max)) Small amount of blood [3 lavender topped tubes] will be collected from subject to test for hemoglobin, type \& screen and 1 cross match to verify the donated blood received from The Blood Connection belongs to the same subject who arrives at the appointed date at Duke facility
Anemic VO2max Three minutes of resting baseline measures will be recorded before the start of exercise. The subject will then begin to pedal the cycle ergometer at a cadence of 75 rpm. Resistance will be manually set according to a standardized, progressive protocol. A rating of perceived exertion (RPE) will be obtained at the end of each exercise stage. Vital signs will be recorded every 3 minutes, and ECG monitoring will be continuous. Exercise will be terminated when the subject reaches volitional fatigue. VO2max will be reported as the highest oxygen consumption averaged over two 30-second periods, which typically occurs in the last stage of the progressive maximal exercise test. Maximum heart rate will be the heart rate at or near VO2max. To minimize variability in VO2max testing procedures, the same 2 facilitators (an engineer/technician and a research staff) will be present at every test. Radial arterial access will be obtained for cardiac output monitoring (LiDCO pulse contour analysis) at this visit.
Tx and post-Tx VO2max Duke Transfusion Services will randomize each subject to receive 2 units of standard PRBCs or rejRBCs over 120 minutes using a standard infusion pump. All units will be washed to equalize the transfusion volumes; rejuvenation includes a mandatory washing step. Rejuvenation of donated blood will be done according to the procedures in the labeling of the Rejuvesol product. Vital signs will be monitored and recorded every 15 minutes. After a total 4-hour rest after completing the first VO2max testing, and a light snack, the exercise test will be repeated.
Laboratory testing: The p50 will be measured in one of the blood units transfused and in the subject before the exercise test. Radial arterial access will be obtained for serial cardiac output monitoring (LiDCO Pulse Contour Analysis, LiDCO Products, London, UK), arterial blood gas analysis and lactate measurement before and after transfusion, and after exercise testing. Final blood collected for a hemoglobin level will be done at the conclusion of blood transfusion. This is the final visit and participation is completed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized "healthy volunteer" study
| Arm | Type | Receives |
|---|---|---|
| Rejuvenated RBC Transfusion | Experimental | Biological: Transfusion of rejuvenated and washed autolgous RBCsWashed and Rejuvenated autologous blood |
| Standard RBC Transfusion | Sham comparator | Biological: Transfusion of washed autolgous RBCsWashed autologous blood (so as to maintain equivalent unit volume and Hct) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy male or female
- Age 18-40 (the American College of Sports Medicine Guidelines for Exercise Testing defines this age group with no or no more than one coronary heart disease risk factor as low-risk for VO2 max testing)
- Habitual exerciser defined as ≥ 30 minutes of at least moderate or high intensity exercise ≥ 3 times per week. After consent, and at the subsequent screening visit, a VO2 max test will be performed, and subjects with a low value (< 35 mL/kg/min) will be excluded (screen failure). Based on our previous experience, we anticipate that up to 25% of the subjects will fall into this category; therefore, 10 subjects will be screened to obtain 6-8 participants who go on to donate their blood.
- Calculated total blood volume of at least 4,500 mL using an established formula:
- Has access to transportation to visit the blood collection facility and to return to Duke for all study visits
Key exclusion criteria (16 listed)
- Any significant acute or chronic medical illness or problem, including, but not limited to, diabetes, hypertension, cardiac disease, asthma, COPD
- Current or recent (last 60 days) tobacco or nicotine use
- History of sickle cell trait or disease or any other acquired or hereditary hematological abnormality
- History of fainting or other significant adverse reaction during phlebotomy or donation of blood
- Known prolonged QTc (or evidence of such at screening) defined as QTc >470 ms
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 |
|---|---|---|
| Transfusion of rejuvenated and washed autolgous RBCsRejuvenation refers to the process of adding a mix of solutes (Rejuvesol®, Citra Labs, Braintree, MA; consists of sodium pyruvate, inosine, adenine, mono- and dibasic sodium phosphate) to older, stored (i.e., 2-3 DPG-depleted) blood to immediately restore 2,3-DPG and ATP levels in the stored red blood cells15. Rejuvenation was originally developed to prolong the storage life of rare-phenotype RBC units. It is FDA-approved for use in RBC units stored in CPD, CPDA-1, and AS-1. The major contraindication for the use of Rejuvesol® is in RBC units stored for fewer than 6 days due to high baseline 2,3-DPG and ATP levels. Rejuvenated units must be washed prior to administration to remove residual Rejuvesol that is not approved for iv administration in such concentrations. | Biological | Rejuvenated RBC Transfusion |
| Transfusion of washed autolgous RBCsAutologous RBCs will be washed prior to transfusion to maintain blinding and equalize volume and Hct with the rejuvenated and washed intervention arm | Biological | Standard RBC Transfusion |
Primary outcome
Change in VO2max
Time frame: Day 16 to Day 18 post transfusion
Change in VO2max from "anemic" (pre-transfusion) VO2max and after transfusion of 2 units of either standard PRBCs or rej-PRBCs "post-Tx" VO2max.
Change in Lactate
Time frame: Day 16 to Day 18 post transfusion
Change in lactate from "anemic" (pre-transfusion) VO2max and after transfusion of 2 units of either standard PRBCs or rej-PRBCs "post-Tx" VO2max
1 secondary outcome
Change in "Post-Tx" VO2max From Baseline
Time frame: Baseline to Day 18 post transfusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ian J Welsby, BSc MBBS principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transfusion of rejuvenated and washed autolgous RBCs and Transfusion of washed autolgous RBCs in people with Erythrocyte Transfusion, run by Duke 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 8 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 11 Jan 2021. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 11 Jan 2021). 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?
Change in VO2max (time frame: Day 16 to Day 18 post transfusion). The study lists 2 primary outcomes in all. 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 11 Jan 2021.