Thrombotic MicroangiopathiesASARD-TMANCT05996679
Automated Surveillance, Alert, and Rapid Diagnosis of Thrombotic Microangiopathies: the ASARD-TMA Study
An observational study of Thrombotic Microangiopathies, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Thrombotic Microangiopathies
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- 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.
Who may be able to join
- 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
Who cannot join
- Patients with a predictive probability of TMA < 90% (6) according to the diagnostic algorithm
About this study
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
- Medical subject headings
- Thrombotic Microangiopathies
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombotic MicroangiopathiesStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DE STEFANO VALERIO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996679
- Sponsor's protocol ID
- 5761
- Acronym
- ASARD-TMA
- Status last verified
- Aug 2023
- First submitted
- 10 Aug 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Surveillance, Alert, and Rapid Diagnosis of Thrombotic Microangiopathies: the ASARD-TMA Study
- ClinicalTrials.gov ID
- NCT05996679
- Acronym / sponsor ID
- ASARD-TMA / 5761
- Conditions
- Thrombotic Microangiopathies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with a predictive probability of TMA < 90% (6) according to the diagnostic algorithm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time of diagnosis and treatment of Thrombotic microangiopathies
Time frame: 24 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombotic Microangiopathies, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of diagnosis and treatment of Thrombotic microangiopathies (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.