RECRUITING

Recombinant VWF Concentrate and ECMO

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Adult patients on extracoporeal membrane oxygenation (ECMO) frequently experience bleeding, which is in part caused by acquired von Willebrand syndrome (vWS). Prior in vitro studies have shown that the addition of recombinant von Willebrand Factor (vWF) to ECMO patient blood samples, normalizes platelet adhesion and thrombus formation. This study is a phase I study, where adult ECMO patients with refractory bleeding will be treated with recombinant vWF a single time. The primary objectives are to evaluate the safety, tolerability, and pharmacokinetics of recombinant vWF in adult ECMO patients.

Official Title

Safety and Tolerability of Recombinant Von Willebrand Factor Concentrate in Adult ECMO Patients with Major Bleeding: a Phase I Study

Quick Facts

Study Start:2024-10-03

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06118372

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Michael Mazzeffi, MD

CONTACT

434-924-9520

syy4wa@uvahealth.org

Keita Ikeda, PhD

CONTACT

434-924-2283

KI2D@uvahealth.org

Principal Investigator

Michael Mazzeffi, MD

PRINCIPAL_INVESTIGATOR

UVA

Study Locations (Sites)

UVA Hospital

Charlottesville, Virginia, 22903

United States

Collaborators and Investigators

Sponsor: University of Virginia

Michael Mazzeffi, MD, PRINCIPAL_INVESTIGATOR, UVA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-03

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-10-03

Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

Bleeding Disorder