## Protocol Section
### Identification Module
**NCT ID:** NCT05996679

**Acronym:** ASARD-TMA

**Brief Title:** Automated Surveillance, Alert, and Rapid Diagnosis of Thrombotic Microangiopathies: the ASARD-TMA Study

**Official Title:** Automated Surveillance, Alert, and Rapid Diagnosis of Thrombotic Microangiopathies: the ASARD-TMA Study

#### Organization Study ID Info
**ID:** 5761
#### Organization
**Class:** OTHER
**Full Name:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS
### Status Module
#### Completion Date
**Date:** 2025-10-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-08-18

**Type:** ACTUAL

**Last Update Submit Date:** 2023-08-10

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-10-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-10-01

**Type:** ESTIMATED

**Status Verified Date:** 2023-08

#### Study First Post Date
**Date:** 2023-08-18
**Type:** ACTUAL
**Study First Submit Date:** 2023-08-10
**Study First Submit QC Date:** 2023-08-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS

#### Responsible Party

**Investigator Affiliation:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS

**Investigator Full Name:** DE STEFANO VALERIO

**Investigator Title:** Full Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Recently a pilot study was conducted to evaluate the impact of an electronic alert (e-alert) triggered by the automated algorithm in the efficiency and rapidity in TMA patients' identification in our University Hospital A. Gemelli over 12 months.the TMA diagnostic algorithm has been implemented in the laboratory software of the hospital and applied whenever a patient in the Emergency ward or any other department undergoes blood tests that include platelet count and lactate dehydrogenase. The basic profile in the Emergency ward always has these two parameters. The algorithm automatically identifies patients with a predicted probability of TMA \>90% (6); if this criterion is associated with a platelet count\<100 x 109/L, an automated warning to the hematologist on-call is issued with an SMS, and the patient enters the TMA diagnostic process defined in the diagnostic and treatment pathways (Percorso Diagnostico e Terapeutico Assistensiale, PDTA). The on-duty hematologist urgently evaluates the patient for whom a warning has been issued, relating with the clinician(s) of the ward in which the patient is located. If the suspicion of TMA is confirmed, the diagnostic procedures outlined in the PDTA are performed, with the immediate execution of 2nd level tests. If the on-duty hematologist considers the diagnosis of aHUS possible, they contact the on-call Nephrologist directly for immediate diagnostic investigation and specific urgent therapeutic measures, as needed. The TMA-expert Hematologist and/or TMA-expert Nephrologist is notified as soon as possible by the on-duty hematologist of all cases, both highly suspected and uncertain, and follow up all patients to complete the diagnostic workup to confirm or rule out the diagnosis and implement the appropriate clinical measures.

Therefore, the treatment in smaller hospitals that do not have a 24-hour hematological guard service available and the same awareness for TMA.

The present study aims to validate these results by testing the system in a multicenter study involving centers with different availability of the hematologist and awareness for TMA.

### Conditions Module

**Conditions:**

- Thrombotic Microangiopathies

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 29

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** Evaluating algorithm to speed up diagnosis and treatment of TMA in smaller hospitals that do not have a 24-hour hematological guard service available and the same awareness for TMA.

**Measure:** Time of diagnosis and treatment of Thrombotic microangiopathies

**Time Frame:** 24 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Patients admitted to the Emergency ward or inpatients of the involved Hospitals with suspicion of TMA:

* Based on the clinical evaluation of the care physicians
* Based on the alerts issued by the automated algorithm

Exclusion Criteria:

* Patients with a predictive probability of TMA \< 90% (6) according to the diagnostic algorithm

**Maximum Age:** 100 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** The study will be conducted in 4 Hospitals (Nefrologia e Dialisi Ospedale Maggiore Verona; Area Aggregata di Ematologia, Fondazione Policlinico Tor Vergata, Roma; Nefrologia e Dialisi ASST Santi Paolo e Carlo, Università di Milano; Nefrologia e Dialisi AOU G. Martino - Università degli Studi di Messina) over 12 months.

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000013921

- Term: Thrombocytopenia

- ID: D000001791

- Term: Blood Platelet Disorders

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000095542

- Term: Cytopenia

### Condition Browse Module - Browse Branches

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M28682

- Name: Thrombotic Microangiopathies

- Relevance: HIGH

- As Found: Thrombotic Microangiopathy

- ID: M17400

- Name: Vascular Diseases

- Relevance: HIGH

- As Found: Microangiopathy

- ID: M16680

- Name: Thrombocytopenia

- Relevance: LOW

- As Found: Unknown

- ID: M5072

- Name: Blood Platelet Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3170

- Name: Cytopenia

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014652

- Term: Vascular Diseases

- ID: D000057049

- Term: Thrombotic Microangiopathies

### Misc Info Module

- Version Holder: 2024-05-24
