NEUVITAL V Study

Authors
Category Primary study
Registry of TrialsRegistro Público Cubano de Ensayos Clínicos
Year 2011
INTERVENTION: Treatment with G‐CSF was administered as random list, as follows: Group I (Hebervital) x 20ug kg daily (divided into 2 sub‐doses of 10 mg x kg body weight every 12 hours), subcutaneously for 2 days. Group II (iorLeukoCIM) x 20ug kg daily (divided into 2 sub‐doses of 10 mg x kg body weight every 12 hours), subcutaneously for 2 days. At 3 hours after the last dose (administered to each study group) will take count of peripheral blood leukocytes, if it is larger than 20 x 109 / L, the procedure to obtain the parents. If the count is less than the mobilization will continue every 12 hours until the leukocyte count above or up to 5 days of treatment. Treatment will be discontinued in any of the 2 groups if the Leucogram are 50 x 109 / L. CONDITION: Patients that need peripheral blood cells mobilization for regenerative therapy (chronic wounds, arterial or venous insufficiency, opened fracture). PRIMARY OUTCOME: CD34+ cells count in aphaeresis, during the aphaeresis. CD34+ cells count in peripheral blood, before mobilization, after the 4th doses and at the end of treatment if it is extended. SECONDARY OUTCOME: White Blood Count (WBC), before mobilization, daily during treatment and before the aphaeresis. Absolute Neutrophil Count (ANC), before inclusion, daily until the end of treatment. Mononuclear cells in peripheral blood and aphaeresis, before inclusion, daily until the end of treatment. Aphaeresis volume, during aphaeresis. INCLUSION CRITERIA: 1.Age major than 18 years old. 2.Informed consent. 3.Patients requiring peripheral blood cells mobilization. 4.ANC within normal limits before inclusion (ANC = 3 x 109/L). 5.Platelet Blood Count within normal limits before inclusion (PBC = 150 x 109/L).
Epistemonikos ID: 27aa3cab50930f153331c02c9c827fa4371e26e7
First added on: Aug 22, 2024