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Blood platelet trends may reveal hidden risk in autoimmune disease

NCT ID NCT07757789

Knowledge-focused Sponsor: New Valley University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This study investigates whether changes in platelet counts over time can serve as a dynamic biomarker for disease severity and survival in people with antiphospholipid syndrome (APS), an autoimmune condition that increases blood clot risk. Researchers will track platelet counts from routine visits and hospitalizations in 200 adults with APS, grouping patients into patterns such as stable normal, transient, fluctuating, or persistent low platelet levels. The goal is to see if these patterns correlate with the risk of death or recurrent blood clots, potentially offering a simple way to identify those who need closer monitoring.

What this could mean

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

Active substance
Longitudinal platelet count monitoring (diagnostic test)
What this could lead to
If successful, this could establish platelet count patterns as a simple, widely available biomarker to identify high-risk APS patients earlier and guide more aggressive management.
What could go wrong
This is an observational study, so it cannot prove cause and effect. The findings may not apply to all APS patients, and the trajectory patterns may not reliably predict outcomes in every individual.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

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.

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: * Age ≥18 years. * Definite APS by Sydney criteria (thrombotic and/or obstetric) with persistent aPL positivity. * ≥3 documented platelet counts over ≥12 months before inclusion (to allow trajectory modeling) Exclusion Criteria: * Thrombocytopenia clearly attributable to non APS causes (e.g., chemotherapy, myelodysplastic syndromes, cirrhosis, HIV). * Concomitant conditions strongly affecting survival independent of APS (e.g., metastatic cancer), at investigator discretion

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Conditions

The condition(s) this trial relates to.

antiphospholipid syndrome thrombocytopenia

As listed by the trial registrant

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

Antiphospholipid syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • New Valley University

    RECRUITING

    Al Khārjah, Kharga Oasis, 72511, Egypt

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