Studies of Pediatric Liver Transplantation

Although liver transplantation is the standard of care therapy for life-threatening liver diseases, the majority of data on the long-term impact of liver transplantation in children have been limited to single-center experiences. The Studies of Pediatric Liver Transplantation (SPLIT) study was designed as a multicenter, observational study to collect prospective data on pediatric patients receiving liver transplantation. Established in 1995, the study aims to characterize and follow trends in patient and graft survival, rejection incidence, growth parameters, and immunosuppressive therapy. Additional study objectives include identifying potential risk factors for patient morbidity and mortality and graft survival.

Patients under 18 years of age who are scheduled for liver transplantation are enrolled at 45 clinical centers. Participants are followed every 6 months for 2 years, and then yearly from the time of listing to transplant. Following transplant, enrolled patients are followed every 6 months for 2 years, and then yearly thereafter until they reach 18 years of age. Data are collected on demographics, primary diagnosis, pretransplant conditions and morbidity, surgical data, and perioperative and long-term morbidity (such as lymphoproliferative disease, rejection, retransplantation, and death).

The data collected in the SPLIT database have been used for various analyses regarding long-term outcomes and risk factors of pediatric liver transplantation. The SPLIT study is ongoing.

While the original SPLIT pediatric registry began in 1995, the NIDDK became the sponsor of SPLIT starting in 2004. Only data collected since 2004, during the time NIDDK sponsored the study, are included in the repository.

尽管肝移植是治疗致死性肝脏疾病的标准治疗方案，但目前关于儿童肝移植长期效应的多数研究数据仍仅来自单中心经验。儿童肝移植研究（Studies of Pediatric Liver Transplantation, SPLIT）是一项多中心观察性研究，旨在收集接受肝移植的儿童患者的前瞻性数据。该研究于1995年启动，旨在阐明并追踪患者与移植物存活、排斥反应发生率、生长参数及免疫抑制治疗的发展趋势。其附加研究目标包括明确患者并发症、死亡及移植物存活的潜在风险因素。

年龄未满18岁、拟接受肝移植的患者可在45个临床中心入组。受试者在移植等待登记至手术完成期间的随访方案为：前2年每6个月随访1次，之后改为每年随访1次。移植术后，入组患者前2年每6个月随访1次，此后每年随访1次，直至年满18岁。研究收集的资料包括人口统计学信息、初始诊断、移植前状态与并发症、手术相关数据，以及围手术期与长期并发症（如淋巴细胞增生性疾病、排斥反应、再次肝移植及死亡）。

SPLIT数据库收录的数据已被用于多项儿童肝移植长期结局及风险因素相关的分析研究。目前该研究仍在持续进行中。

尽管SPLIT儿童登记库最初于1995年启动，但美国国立糖尿病、消化和肾脏疾病研究所（National Institute of Diabetes and Digestive and Kidney Diseases, NIDDK）自2004年起成为该研究的资助方。本数据集仅收录2004年起由NIDDK资助研究期间收集的数据。