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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paediatric patients receiving HCTS with infectious complications post HCTS | Paediatric patients receiving allogeneic hematopoietic stem cell transplantation (HCTS) and who 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-ES-, graft failure, thrombotic microangiopathy associated with HSCT- TA-TMA or those without complications post HSCT). |
| |
| Paediatric patients receiving HCTS without infectious complications post HCTS | Paediatric patients receiving HCTS without infectious complications post HCTS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| observation | Other | observation and prospective data collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric and young adult patients affected by malignant or non-malignant disorders referred for HCST
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Celeste Cagnazzo, PhD | Contact | 00390113135171 | celeste.cagnazzo@unito.it |
| Name | Affiliation | Role |
|---|---|---|
| Franca Fagioli, MD | AOU Città della Salute e della Scienza di Torino - OIRM | Principal Investigator |
| Manuela Spadea, MD | AOU Città della Salute e della Scienza di Torino - OIRM | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita | Recruiting | Turin | 10126 | Italy |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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Blood sample collection will be performed on T1 (first day of fever or day in ich a transplant-related complication is diagnosed), T2 (3 days after T1), T3 (10 days after T1). It will be analysed PCT and pro-ADM values