Pharmacokinetic Study of Lipo-PGE1 for Prevention of VOD After HSCT
Status:
Active, not recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
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).