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Can a clotting factor stop bleeding in ECMO patients?

NCT ID NCT06118372

Disease control Sponsor: University of Virginia 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests a single dose of a lab-made clotting protein (recombinant von Willebrand factor) in 12 adult patients on ECMO who have major bleeding. The goal is to see if the drug is safe and how it behaves in the body. If successful, it may lead to a new way to control bleeding in this high-risk group.

What this could mean

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

Active substance
Recombinant von Willebrand Factor (a lab-made blood clotting protein)
What this could lead to
If it works, this could point toward a treatment to control severe bleeding in ECMO patients, potentially reducing complications and improving survival.
What could go wrong
This is a very early, small phase I trial with only 12 participants, so results may not apply to all patients. The drug could cause serious side effects or fail to stop bleeding.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 12 people

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

Started

Oct 2024

Expected to finish

Feb 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: 1. Adult patients (18 years or greater) 2. On extracorporeal membrane oxygenation 3. Major bleeding defined by CTCAE class 3 or greater 4. Off systemic anticoagulation for at least 4 hours Exclusion Criteria: 1. Platelet count less than 40 x 109/L 2. International normalized ratio\> 2.0 3. Fibrinogen less than 150 mg/dL 4. Current participation in another clinical trial (interventional) 5. Heparin induced thrombocytopenia (active) 6. Acute liver failure, as indicated by bilirubin \>20 mg/dL or new onset hepatic encephalopathy 7. Patient or legally authorized representative unable to give informed consent 8. Allergy to recombinant von Willebrand Factor or any component of the product based on prior exposure 9. Of childbearing age and positive pregnancy test during the same hospital admission, a pregnancy test will be mandatory for all women of child-bearing age 10. Known congenital or acquired thrombophilia 11. History of deep venous thrombosis, pulmonary embolism, circuit thrombosis, disseminated intravascular coagulation (DIC), ischemic stroke, ST elevation myocardial infarction (STEMI), or arterial thrombosis in the last 3 months. 12. History of hypersensitivity to vWF concentrate 13. Known history of vWF antibodies

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Conditions

The condition(s) this trial relates to.

acquired von willebrand syndrome hemorrhagic disease vascular hemostatic disease

As listed by the trial registrant

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

Bleeding disorder

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

  • UVA Hospital

    RECRUITING

    Charlottesville, Virginia, 22903, United States

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