Hidden blood disorder may explain mysterious strokes in young adults

NCT ID NCT03329365

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 This study
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 Results may not be published yet.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

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare blood disorder that can cause dangerous blood clots. Researchers want to know how often PNH appears in people under 50 who have had a stroke, mini-stroke, or brain vein clot with no clear cause. The study will screen 200 participants with a blood test called flow cytometry to look for PNH. Finding the disorder could help doctors identify a treatable cause of these unexplained events.

What this could mean

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

Active substance
flow cytometry blood testing for paroxysmal nocturnal hemoglobinuria
What this could lead to
If the link holds, doctors could routinely screen young stroke patients for this rare blood disorder and treat the underlying cause to prevent future clots.
What could go wrong
This is an observational study, so it cannot prove that PNH causes these strokes. The disorder may turn out to be too rare in this group to justify widespread screening.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

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

Started

Nov 2018

Expected to finish

Mar 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.

Who is studied

Patients with ESUS, ETUS, or SSS-CVTUS attending the Urgent TIA and Stroke Prevention Clinic or admitted to University or Victoria Hospital, in London, Ontario, Canada.

Ages

18 to 50 years

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: General: * Participants with embolic ischemic stroke (ESUS), embolic transient ischemic attack (ETUS) or cerebral venous thrombosis (CVTUS) of undetermined source. For transient ischemic attack (TIA): One of the following criteria needs to be fulfilled to be considered as embolic TIA: * Focal symptoms suggesting involvement of de cerebral cortex in the middle cerebral artery (MCA) territory (e.g., aphasia, neglect, apraxia, dystextia, anosognosia, isolated leg, arm or hand weakness). Some of these symptoms have been described as associated with subcortical fibers connecting cortical areas as well but, despite this, they are usually related to cortical localizations. Patients with hemianopia will be included only if hemianopia is not the primary symptom or an isolated symptom. * Rapidly resolving hemispheric symptoms. This concept comprises two components: (a) sudden onset hemispheric syndrome: sudden onset of symptoms and signs implicating extensive ischemia in the internal carotid artery (ICA) or MCA territories, including hemiparesis, hemianopia, conjugate eye deviation, other cortical signs, or altered consciousness; and (b) spectacular shrinking deficit: improvement within 24 hours (approximately). * Symptoms involving more than one vascular territory within a single hemisphere (e.g. left sided weakness + left homonymous hemianopia) or both (e.g., left sided weakness and aphasia in a right-handed patient). * Simultaneous embolization to other organs (e.g., bowel, spleen, liver, kidneys, toes). * Transient monocular blindness (amaurosis fugax) with no evidence of giant cell arteritis (e.g., normal erythrocyte sedimentation rate). * No definite cortical symptoms but neuroimaging evidence of prior (chronic) typical infarct (wedge shaped, involving the cerebral cortex). All of the following criteria must be fulfilled to be considered as TIA of undetermined source: * No neuroimaging evidence of an acute brain infarct within the brain region(s) responsible for the presenting symptoms. * Absence of extracranial or intracranial atherosclerosis causing ≥50% luminal stenosis in arteries supplying the area of ischemia. * No major-risk cardioembolic source of embolism. * No other specific cause of stroke identified (e.g., arteritis, dissection, migraine, vasospasm, or drug abuse). * No persistent neurological focal symptoms at the time of neurological examination. The presence of persistent neurological focal symptoms in the absence of a visible brain infarct on DWI MRI will be regarded as a "clinically confirmed stroke with negative DWI MRI". Exclusion Criteria: General: * Inability to provide informed consent For stroke patients: * Evidence of \>50% stenosis of the internal carotid artery (ICA) or MCA ipsilateral to the qualifying ischemic stroke on neurovascular imaging studies. * Ischemic stroke involving deep structures and measuring \< 15 mm on diffusion-weighted (DWI) magnetic resonance imaging (MRI). Cortical strokes measuring \<15 mm will qualify to be included in the study. * Evidence of a cause explaining the stroke (e.g. hypercoagulable state or any other major source of cardiac embolism). For TIA patients: * Patients no fulfilling the criteria for ETUS. For cerebral venous thrombosis patients: * Subjects without involvement of the superior sagittal sinus (SSS) * Subjects with an evident cause explaining the thrombosis (e.g., thrombophilia)

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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

  • London Health Sciences Centre

    London, Ontario, N6A5A5, Canada

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