Prospective Non-Interventional Trial to Evaluate Kinetics, Diagnostic and Prognostic Value of Pro-ADM as Compared to PCT in Patients Presenting With Infections or Other Complications Post Hematopoietic Stem Cell Transplantation (HSCT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Evaluation of diagnostic performance of pro-ADM as compared to PCT in patients receiving HSCT
研究概览
简要总结
Prospective, multicenter, spontaneous, non-interventional, non pharmacological. Study aimed at evaluate kinetics, diagnostic and prognostic value of pro-ADM (proadrenomedullin) as compared to PCT (procalcitonin) in patients presenting with infections or other complications post hematopoietic stem cell transplantation (HSCT)
详细描述
Evaluation of diagnostic performance of pro-ADM as compared to palliative care therapy (PCT) in paediatric and young adult patients with any type of complications after hematopoietic stem cell transplantation or with transplant related complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 28 Days 至 39 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent of the parents/legal guardians and patient's assent/consent according to national regulations. For subjects who turn 18 years of age during participation in this study, participation in the future use portion of the study after their 18th birthday requires that they sign the informed consent statement following turning 18 years of age.
- •Age at time of registration from 28 days to less than 39 years of age.
- •Malignant disease (i.e. Acute lymphocytic leukemia (ALL), Acute myeloid leukemia (AML), Myelodysplastic syndromes (MDS)) or nonmalignant disease (e.g. immunodeficiency or inherited disorders of metabolism or hemoglobinopathies etc.) indicated for allogeneic HSCT.
排除标准
- •Age less than 28 days
- •Obese patients with body mass index: > 30 kg/m^
- •Impaired cardiac function: severe cardiac insufficiency indicated by left ventricle ejection fraction (LVEF) ≤ 35%.
- •Impaired liver function indicated by Bilirubin >3 times the upper limit of normal (ULN), or aspartate aminotransferase/alanine aminotransferase (AST/ALT) >10 times ULN
- •Impaired renal function indicated by estimated glomerular filtration rate (GFR), according to the Schwartz formula for ages 1-17 and according to CDKEPI creatinine equation for ages above 17 years old) < 60 mL/min/1,73m^
- •Concurrent severe active infection at the start of conditioning regimen
结局指标
主要结局
Evaluation of diagnostic performance of pro-ADM as compared to PCT in patients receiving HSCT
时间窗: 180 days after HSCT
In order to achieve the objective, it will be considered paediatric and young adults patients affected by malignant/non-malignant disorders who have been subjected to HSCT and present with infectious complications post HSCT or with transplant related complications (acute graft-versus-host disease (GvHD), sinusoidal obstruction syndrome (SOS), engraftment (ES) and pre-engraftment syndrome (pre-E), graft failure, thrombotic microangiopathy associated with HSCT (TA-TMA) or those without complications post HSCT).
次要结局
未报告次要终点
研究者
Prof. Franca Fagioli
Prof
Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna