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

NCT05996679 | Unknown

• 1 other identifier: 5761
• Study Type: observational
• Target: 29
• Locations: 0 countries
• Sites: N/A

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

Thrombotic Microangiopathies

Outcome Measures

Primary Outcomes (1)

• Time of diagnosis and treatment of Thrombotic microangiopathies

  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.

  24 months

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Thrombotic Microangiopathies

Condition Hierarchy (Ancestors)

Thrombocytopenia; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 18, 2023
• Study Start: October 1, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 18, 2023

Record last verified: 2023-08