New rapid test could speed up diagnosis of deadly blood clotting disorder
NCT ID NCT05046717
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a new, faster blood test for diagnosing acquired thrombotic thrombocytopenic purpura (aTTP), a rare but life-threatening blood clotting disorder. The new test, called HemosIL AcuStar, will be compared to two existing tests in 500 patients from Spain and Portugal. The goal is to see if it can diagnose severe ADAMTS13 deficiency more quickly and accurately, which could help doctors start life-saving treatment sooner.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ADAMTS13 activity test (HemosIL AcuStar chemiluminescent assay)
- What this could lead to
- If successful, this could lead to faster and more accurate diagnosis of TTP, helping doctors start the right treatment sooner and potentially saving lives.
- What could go wrong
- This is a diagnostic validation study, not a treatment trial. The new test may not prove significantly better than existing methods, and results may not apply to all populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2022
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population will be all consecutive patients who meet the following inclusion criteria and none of the following exclusion criteria until reaching the number of patients determined for the study.
- Ages
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0 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with confirmed thrombotic microangiopathy (TMA) based on citrated blood samples meeting both of the following criteria: * Thrombocytopenia \[drop in platelet count ≥50% or platelet count \< 100x109/L and * Microangiopathic haemolytic anaemia (elevation of lactate dehydrogenase (LDH) \>2- fold or by presence or increase of schistocytes in peripheral blood smear) * Patients that voluntarily sign informed consent. For subjects unable to provide consent, a fully recognized medical proxy may be used according to local laws. * Patients between 0 to 99 years old at the time of screening. Exclusion Criteria: \-
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centro Hospitalar e Universitario de Coimbra
Coimbra, Coimbra District, 3004-561, Portugal
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Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña, 15006, Spain
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Hospital Clinic de Barcelona
Barcelona, Spain
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Hospital Clínico San Carlos
Madrid, Spain
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Hospital Gregorio Marañon
Madrid, Spain
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Hospital La Fe de Valencia
Valencia, Spain
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