Clinical trial NCT05523336: Pro-ADM vs PCT in Patients With Complications Post Hematopoietic Stem Cell Transplantation
Official title: 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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stem Cell Transplant Complications
Lead sponsor: Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
Sponsor class: OTHER
First posted: 2022-08-31
Enrollment: 200
Sex: ALL
Minimum age (years): 28
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric and young adult patients affected by malignant or non-malignant disorders referred for HCST

Brief summary: 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)

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Age less than 28 days
* Obese patients with body mass index: \> 30 kg/m\^2.
* 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\^2.
* Concurrent severe active infection at the start of conditioning regimen

Primary outcomes:
measure: Evaluation of diagnostic performance of pro-ADM as compared to PCT in patients receiving HSCT
timeFrame: 180 days after HSCT
Secondary outcomes:
Other outcomes:
Locations:
city: Turin
country: Italy
facility: AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita
Study officials:
affiliation: AOU Città della Salute e della Scienza di Torino - OIRM
name: Franca Fagioli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AOU Città della Salute e della Scienza di Torino - OIRM
name: Manuela Spadea, MD
role: STUDY_CHAIR
References: