Eligibility Details:
Eligibility Criteria
Recruiting and studying of healthy human subjects with no pre-existing pathologic
conditions from the local population. As a result the inclusion criteria is deliberately
broad.
Inclusion Criteria
1. Hemoglobin > 12 g/dl
2. Healthy, non-pregnant adults with no pre-existing blood disorders or disease states
that impact oxygen delivery.
2a. Active blood and platelet donors will be sought as study participants since these
individuals are familiar with the routines for blood withdrawal and re-infusion.
Exclusion Criteria
The exclusion criteria is derived from the American Red Cross(ARC) Standard Operating
Procedure (SOP) for autologous donation AND the parameters set out in the investigational
new drug application (IND).
1. Individuals who are pregnant, breastfeeding, or are unwilling to avoid pregnancy
during the study.
2. Individuals with an anatomic anomaly that would increase the risks associated with
placement of the vascular catheters.
3. Individuals who report chronic diseases requiring medication of the heart, lungs,
kidney, liver, etc or afflicted with any acute or chronic pathology that in the
opinion of the screening physician makes them unsuitable for study.
4. Individuals with a recent history of antibiotic therapy (check for underlying cause).
5. Individuals unwilling to refrain from taking any phosphodiesterase 5 (PDE-5) inhibitor
for at least 24 h prior to donation and/or autologous transfusion.
6. Individuals taking a vitamin K antagonist (warfarin) or other anticoagulant (e.g.
heparin, clopidogrel, enoxaparin or dalteparin).
7. Individuals taking allopurinol, beta-adrenergic blockers, tricyclic antidepressants,
meperidine (or related central nervous system (CNS) agents), or nitrates.
8. Individuals on long-term antihistamine therapy 8a. The study physician will determine
on a case by case basis the suitability for inclusion of individuals who control
seasonal or acute allergies with occasional antihistamine use.
9. Individuals with blood pressure parameters outside the normal range of 90-180 mm Hg
systolic and 50-100 mm Hg diastolic.
10. Individuals with heart rates outside the range of 50 to 100 beats per minutes or with
a pathologic irregularity.
10a. Pulses lower than 50 may be acceptable if the study participant participates in
endurance training. The study physician will be consulted for evaluation.
11. Individuals with an inherited or acquired blood coagulation disorder, congenital
methemoglobinemia, or a familial hemoglobinopathy that impacts oxygen delivery (e.g. sickle
cell).
12. Individuals with any illness that may increase the risks associated with the study.
13. Individuals who previously received blood products to treat an acute condition will be
evaluated on a case by case basis.
14. Individuals who report an acute or chronic disease state that may impact oxygen
delivery.
15. Individuals with evidence of diminished lung capacity.
16. Individuals who might have difficulty with the placement of a face mask (e.g.
claustrophobia, uncontrolled asthma, severe allergies, sensitive skin) and/or the
inhalation of a product for approximately 1-2 hr.
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
