Child Clinical Trial
Official title:
Pharmacokinetic Study of Lipo-PGE1 for Prevention of VOD After HSCT
Veno-occlusive disease (VOD) after hematopoietic stem cell transplantation (HSCT) remains the major complication. VOD occurs in 11-31% of pediatric HSCT and the mortality reaches up to 50%. Prostaglandin E1 (PGE1) have been reported to prevent and relieve the severity of VOD by Gluckman et al.. Lipo-PGE1 is a transporter of PGE1, which is superior in concentrating PGE1 and acts for prolonged time. Because of the prolonged effective time, lipo-PGE1 acts comparable effects by 1/4~1/8 of PGE1 dose. Empirically, pediatric HSCT centers adopt lipo-PGE1 in dose of 1 mcg/kg/day (0.042 mcg/kg/hr), which is 1/7 of the dose recommended by Gluckman, et al. This prospective study will investigate the concentration of lipo-PGE1 with preventive lipo-PGE1 with empirical dose (1 mcg/kg/day).
Primary Objective: To evaluate the pharmacokinetics of lipo-PGE1. Secondary objective: To evaluate the relation between lipo-PGE1 concentration and VOD occurrence, severity. Inclusion criteria 1. Patients undergoing HSCT with high risk of VOD who cannot use low dose heparin. - high risk of VOD : previous radiotherapy, liver function abnormality, children, conditioning regimen including busulfan or total body irradiation - contraindication of heparin : low platelet count, bleeding tendency, allergy 2. Patients (or one of parents if patients age < 19) should sign informed consent. Exclusion criteria 1. Patient with heart failure. 2. Patient with bleeding (intracranial hemorrhage, gastrointestinal tract bleeding, hemoptysis). 3. History of hypersensitivity reaction as shock to lipo-PGE1. 4. Psychiatric disorder that would preclude compliance. 5. If the clinician decides that there is a condition improper for the clinical study. ;
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