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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05996679
Acronym
ASARD-TMA
Enrollment
29
Registered
2023-08-18
Start date
2023-10-01
Completion date
2025-10-01
Last updated
2023-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombotic Microangiopathies

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.

Interventions

None listed

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Time of diagnosis and treatment of Thrombotic microangiopathies24 monthsEvaluating 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026