Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT03089047 |
Other study ID # |
Pro00078468 |
Secondary ID |
|
Status |
Terminated |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
September 29, 2017 |
Est. completion date |
April 18, 2018 |
Study information
Verified date |
December 2020 |
Source |
Duke University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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. 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.
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.