Kinetics of Intravenous G-CSF-Induced Granulocyte Mobilization in Healthy Apheresis Donors
Granulocyte colony-stimulating factor
+ Dexamethasone
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juillet 1999
Date à laquelle le premier participant a commencé l'étude.The administration of granulocyte colony-stimulating factor (G-CSF) to increase the white blood cell count in granulocyte donors prior to donation is becoming an increasingly common practice. G-CSF is given subcutaneously to the donor on the day prior to donation, generally 12 to 24 hours before the start of apheresis. It would be advantageous to be able to give G-CSF and collect granulocytes on the same day. However, the single most important factor in optimizing granulocyte collection is the donor's pre-collection granulocyte count. Therefore, any decrease in count would result in a less cellular component. The purpose of this study is to assess granulocyte counts in healthy subjects during an 8-hour period after a single 5 microgram/kg intravenous dose of G-CSF with or without dexamethasone. Sixteen subjects will be studied. Each donor will be studied four separate times. The four mobilization protocols to be studied are G-CSF 5 micrograms/kg given intravenously, G-CSF 5 micrograms/kg subcutaneously, G-CSF 5 micrograms/kg intravenously plus dexamethasone 8 mg orally, and G-CSF 5 micrograms/kg subcutaneously plus dexamethasone 8 mg orally. The order of the route of administration will be assigned randomly. White blood cell counts, neutrophil counts and donor symptoms will be measured before G-CSF administration and at 1/2, 1, 2, 4, 6, 8 and 24 hours after administration. The neutrophil counts measured within the first 8 hours after G-CSF will be compared with counts measured 24 hours after G-CSF.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.16 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Critères
Male and female subjects. Must be 18 years of age or older. Subjects must pass the health criteria for blood donors established by the American Association of Blood Banks. No subjects who are pregnant or lactating females. No subjects with uncontrolled hypertension, heart disease, diabetes, history of allergic reactions to G-CSF, history of allergic reactions to E. coli, abnormal hemoglobin or white blood cell counts, a malignancy, asthma, taking prednisone or using an inhalant. No hemoglobin less than 11.0 or greater than 19.0 gm/dL No platelet counts less than 140 x 10(9)/L or greater than 500 x 10(9)/L. No absolute neutrophil count less than 1.5 x 10(9/)/L or greater than 10.0 x 10(9)/L.
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Warren G. Magnuson Clinical Center (CC)
Bethesda, United StatesOuvrir Warren G. Magnuson Clinical Center (CC) dans Google Maps