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Coagulation Factor

Recombinant vWF Concentrate for Bleeding

Phase 1

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours after treatment

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am 18 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Change in bleeding severity class

Change in bleeding/drain output volume from existing surgical drains

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor

756 Previous Clinical Trials

1,245,286 Total Patients Enrolled

Michael Mazzeffi, MDPrincipal InvestigatorUVA

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks are associated with utilizing recombinant vWF in treatment plans?

"Due to the scarce data backing up efficacy and safety, Treatment with recombinant vWF was judged a 1 out of 3 on our team at Power's scale."

Answered by AI

Is the enrolment period for this clinical experiment still active?

"According to clinicaltrials.gov, the trial is no longer recruiting patients; it was initially posted on January 1st 2024 and last updated November 3rd 2023. However, there are 385 other trials that are still actively taking participants at this point in time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Recombinant vWF Concentrate and ECMO

Michael Mazzeffi, MD 2024. "Recombinant vWF Concentrate and ECMO". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06118372.

All > Ecmo