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Coagulation Factor

Recombinant vWF Concentrate for Bleeding

Phase 1

Recruiting

Led By Michael Mazzeffi, MD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult patients (18 years or greater)

Be older than 18 years old

Must not have

Patient or legally authorized representative unable to give informed consent

Acute liver failure, as indicated by bilirubin >20 mg/dL or new onset hepatic encephalopathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours after treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety & effectiveness of a single treatment of recombinant vWF to reduce bleeding in adult ECMO patients.

Who is the study for?

This trial is for adults on ECMO with major bleeding who aren't on blood thinners for at least 4 hours. It's not for those with recent serious clots, vWF antibodies, low platelets or fibrinogen levels, high INR, liver failure, current trial participation, heparin allergy, inability to consent or pregnancy.

What is being tested?

The study tests a single dose of recombinant von Willebrand Factor (vWF) in adult ECMO patients with severe bleeding. The goal is to see if it's safe and how the body processes it. This phase I study aims to improve clotting by normalizing platelet adhesion.

What are the potential side effects?

Potential side effects may include allergic reactions to the recombinant vWF concentrate and possible complications related to clotting since vWF helps blood clot.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I or my legal representative cannot give informed consent.

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I have severe liver failure with very high bilirubin or sudden confusion due to liver issues.

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I have had a blood clot or stroke in the last 3 months.

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I have antibodies against von Willebrand factor.

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I have a known blood clotting disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours after treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours after treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours after treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Area under the plasma concentration curve from zero to infinity (h × U/dL)

Clearance (mL/kg per hour)

Incremental recovery ([U/dL]/[U VWF: RCo/kg] for VWF)

+6 more

Secondary study objectives

Change in bleeding severity class

Change in bleeding/drain output volume from existing surgical drains

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment with recombinant vWFExperimental Treatment1 Intervention

ECMO patients with major bleeding who are enrolled in the trial will receive treatment with recombinant von Willebrand Factor a single time. The dose will be 50 IU/kg and the drug will be given intravenously.

0 / 6Eligibility criteria met