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临床试验/NCT03419078
NCT03419078已完成不适用

Route and Adequacy of Nutrition and Outcomes of Haematopoietic Cell Transplantation in Patients With Haematological Neoplasms

Imperial College Healthcare NHS Trust0 个研究点目标入组 484 人开始时间: 2015年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
484
主要终点
Number of Participants With Acute Graft Versus Host Disease (GvHD) at Any Site (Grade II or Above) and Acute GvHD of the Gut of Any Grade

研究概览

简要总结

Retrospective case-note review to determine if nutrition via the enteral compared to the parenteral route results in better outcomes after haematopoietic cell transplantation.

详细描述

This is a retrospective case-note review of adults undergoing haematopoietic cell transplantation to treat a haematological malignancy who have been admitted to Hammersmith Hospital from 2000 to 2014. All patients receiving an allogeneic haematopoietic cell transplant from a matched sibling or identically matched unrelated donor will be included. We will record the route and assess the broad adequacy of nutritional intakes to determine if nutrition via the enteral compared to the parenteral route results in better outcomes after haematopoietic cell transplantation. Our outcomes are graft versus host disease incidence and severity, transplant related (early) mortality and overall survival.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
17 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing their first HCT for a hematologic malignancy
  • Undergoing HCT using a sibling or unrelated donor
  • Undergoing HCT infusion between January 2000 and December 2014

排除标准

  • HCT using umbilical cord blood donors
  • HCT using haploidentical donors

结局指标

主要结局

Number of Participants With Acute Graft Versus Host Disease (GvHD) at Any Site (Grade II or Above) and Acute GvHD of the Gut of Any Grade

时间窗: 100 days after the date of hematopoietic cell infusion

Occurrence of acute GvHD at any site (grade II or above) and acute GvHD of the gut of any grade (graded according to standard criteria). Standard criteria to grade the severity of acute GvHD are quantification of rash, serum bilirubin and diarrhoea. These standard criteria have been developed and used for \> 20 years by most transplant centres to improve comparability between publications.

Non Relapse Mortality

时间窗: 100 days after the date of hematopoietic cell infusion

Defined as death without previous relapse

次要结局

  • Graft Versus Host Disease-free and Relapse-free Survival(5 years after the date of hematopoietic cell infusion)
  • 5 Year Survival(5 years after the date of hematopoietic cell infusion)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

JBeckerson

Haemato-Oncology Specialist Dietitian

Imperial College Healthcare NHS Trust

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