Pro-ADM vs PCT in Patients With Complications Post Hematopoietic Stem Cell Transplantation

Stem Cell Transplant Complications Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05523336
• Other study ID #: Trap-ADM
• Status: Recruiting
• Start date: October 20, 2022
• Est. completion date: March 2025

Study information

• Verified date: May 2023
• Source: Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
• Contact: Celeste Cagnazzo, PhD
• Phone: 00390113135171
• Email: celeste.cagnazzo[@]unito.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Days to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Stem Cell Transplant Complications

Intervention

Other:
• observation
observation and prospective data collection

Locations

Country	Name	City	State
Italy	AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita	Turin

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of diagnostic performance of pro-ADM as compared to PCT in patients receiving 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).	180 days after HSCT