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A blood test that could predict clots in autoimmune disease?

NCT ID NCT03890601

Knowledge-focused Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This study looks at whether two additional lab tests can better predict the risk of blood clots in people with antiphospholipid syndrome (APS), an autoimmune condition that can cause clots and pregnancy complications. Researchers will measure specific antibodies and thrombin generation (a measure of blood clotting tendency) in blood samples from 74 adults with APS. They will then compare these results with each person's history of clots or pregnancy issues to see if the tests improve risk assessment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
blood sample
What this could lead to
If successful, this could lead to better blood tests to identify which antiphospholipid syndrome patients are at higher risk of blood clots, enabling more personalized care.
What could go wrong
This is an observational study with a small number of participants. The new tests may not prove more accurate than existing ones, and results may not apply to all patients.

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

74 people

The number who actually took part.

Started

Mar 2019

Finished

May 2023

Lead sponsor

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

150 adult patients with known aPL-Abs (Antiphospholipid antibodies) will be including in the study after collecting their informed consent.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult patients with confirmed aPL-Abs (at least two positive determinations at least 12 week apart) * Subject non opposition Exclusion Criteria: * Age \< 18 years * Patient under the protection of justice, under guardianship or under curatorship * Patient with anticoagulant treatment, except heparin * Clinically symptomatic liver disease, supported by e.g. diagnosis of cirrhosis, portal hypertension, ascites, PT superior or egal to 5 seconds above upper normal limit * Platelet count \< 100 G/L (giga/liter) * Poor venous access * Non confirmed suspicion of APS

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Conditions

The condition(s) this trial relates to.

antiphospholipid syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Antiphospholipid syndrome

Contacts and locations

Locations

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63003, France

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310, France

  • Hôpital Cardiologique Louis Pradel

    Bron, 69500, France

  • Hôpital Edouard Herriot

    Lyon, 69421, France

  • Hôpital de la Croix-Rousse

    Lyon, 69004, France

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