HLH Patients - a Retrospective Study

Completed

• Conditions: Hemophagocytic Lymphohistiocytoses
• Interventions: Other: Observation

• Registration Number: NCT05531721
• Lead Sponsor: Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

Brief Summary

Monocentric, observational, retrospective, no profit study aimed to analyze factors that are significantly impacting the outcome of patients diagnosed with HLH.

Detailed Description

retrospective data collection to study: type of HLH familial vs secondary, sex, age, presence of infectious cause, involvement central nervous system ( SNC), hepatic involvement, presence of hemophagocytosis, presence of splenomegaly, presence of involvement of other organs, the value of neutrophils (PMN), the value of hemoglobin, platelets, albumin, triglycerides, ferritin, LDH, type of therapy and the response to therapy after 2 months

Study Timeline

• Study First Submitted: 2022-08-19
• Study First Submitted QC: 2022-09-07
• Study First Posted: 2022-09-08
• Study Start: 2022-11-10
• Primary Completion: 2023-02-24
• Study Completion: 2023-04-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-23
• Last Update Posted: 2023-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Have received HLH diagnosis according to HLH 2004 criteria
• age ⥶18 years.
• followed at our facility between January 2004 and December 2021
• Whose parents have consented to participation and data processing

Exclusion Criteria

• The study does not foresee specific exclusion criteria other than the non-compliance with the inclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pediatric patients affected by hemophagocytic lymphohistiocytoses	Observation	pediatric patients with HLH

Primary Outcome Measures

Name	Time	Method
physiological parameter that are significantly impacting the outcome of patients diagnosed with HLH	through study completion, an average of 1 year	Type of HLH (familial vs secondary); sex (M or F); age (in year); presence of infectious cause; involvement central nervous system (yes or no); hepatic involvement (yes or no); presence of hemophagocytosis (yes or no); presence of splenomegaly (yes or no); involvement of other organs (yes or no); value of neutrophils (PMN, in 10\^9/L), hemoglobin (in g/dL), platelets (in 10\^9/L), albumin (in g/L), triglycerides (in mg/dL), ferritin (in UI/L) and LDH (in UI/L);

Trial Locations

Locations (1)

AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita; 🇮🇹 Turin, Italy