VO2 Max: In Vivo Model for Functional Red Cell Testing. Can RECESS be Explained?
This is a single-center, randomized, partially blinded study to determine whether 42-day old red blood cells (RBCs) deliver oxygen as effectively as 7-day old RBCs and also to determine whether transfusion with 28-day old RBCs is non-inferior to 7-day old RBCs with respect to oxygen delivery.
In this study, subjects will be randomized to be transfused with 2 units of autologous (one's own) RBCs that are either 7-, 28-, or 42-days old. Endpoints include changes in exercise duration and VO2 max (test of oxygen consumption/delivery) between groups.
Přehled studie
Postavení
Podmínky
Detailní popis
The US Food and Drug Administration (FDA) regulations permit additive-containing RBCs to be stored for up to 42 days prior to transfusion. However, RBCs progressively develop abnormalities during storage. The efficacy of older stored blood, i.e., effective oxygen delivery, has not been established in rigorous controlled studies. Due to pragmatic reasons, a large clinical trial that randomizes patients to "old" blood may not be feasible.
Every subject will have 2 phlebotomy visits at Stony Brook University Hospital. Subjects randomized to the 7- and 42-day old groups will have 2 units of blood removed at Week 0 and another 2 units removed at Week 5. However, the remaining 28-day group will have 2 units of blood removed at Week 2 and only 1 unit of blood removed at Week 5. During week 6, each subjects will have 3 study visits: 1) On Monday, a VO2 max test; 2) On Wednesday, a transfusion with 2 units of autologous RBCs (each over 1 hour), followed by a VO2 max test 2 hours later; 3) On Friday, a VO2 max test will be done in order to calculate a delta VO2 max (Friday minus Monday results).
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 4
Kontakty a umístění
Studijní místa
-
-
New York
-
Stony Brook, New York, Spojené státy, 11794-8480
- Stony Brook Medicine
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- 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 <10% of the subjects will fall into this category
Calculated total blood volume (TBV) ≥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 Stony Brook for all study visits.
Exclusion Criteria:
- Any significant acute or chronic medical illness or problem, including, but not limited to, diabetes, hypertension, cardiac disease, asthma, chronic obstructive lung disease
- 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 corrected QT interval (or evidence of such at screening) on electrocardiogram defined as >470 ms
- Known or suspected illicit drug or alcohol abuse
- 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: a) Single whole blood unit donation within the past 8 weeks; b) Double RBC donation by apheresis within the past 16 weeks; or c) Plasma donation by apheresis within the past 4 weeks
- Inadequate RBC mass based on TBV <4500 ml (above) or screening Hb <14 g/dL
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 7-day old RBCs
Transfusion of 7-day stored red blood cells: Subjects will be transfused with their own 7-day old red blood cells
|
Subjects will donate blood at Week 0 and Week 5 of their participation and receive, at Week 6, back a transfusion of their Week 5 (7-day old) red blood cells.
|
|
Experimentální: 28-day old RBCs
Transfusion of 28-day stored red blood cells: Subjects will be transfused with their own 28-day old red blood cells
|
Subjects will donate blood at Week 2 and Week 5 of their participation and receive, at Week 6, back a transfusion of their Week 2 (28-day old) red blood cells.
|
|
Experimentální: 42-day old RBCs
Transfusion of 42-day stored red blood cells: Subjects will be transfused with their own 42-day old red blood cells
|
Subjects will donate blood at Week 0 and Week 5 of their participation and receive, at Week 6, back a transfusion of their Week0 (42-day old) red blood cells.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Percent Change From Baseline in Maximal Oxygen Uptake (VO2 Max) After Blood Cell Transfusion
Časové okno: Baseline (prior to receiving blood) and Day 2 after receiving blood
|
Percent Change From Baseline in Maximal Oxygen Uptake (VO2 Max) on Day 2 After Blood Cell Transfusion
|
Baseline (prior to receiving blood) and Day 2 after receiving blood
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Percent Change in Duration of Exercise From Baseline to Day 2 After RBC Transfusion
Časové okno: Baseline and Day 2 after transfusion
|
Percent change in duration of exercise from baseline to day 2 after red blood cell transfusion
|
Baseline and Day 2 after transfusion
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Elliott Bennett-Guerrero, MD, Stony Brook University
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 953865
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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