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New treatment option for Bleeding Disorder
Official title Recombinant vWF Concentrate and ECMO
ClinicalTrials.gov ID: NCT06118372
What this study is testing
What is Recombinant von Willebrand Factor?
Recombinant von Willebrand Factor is an investigational medicine, being studied as a potential treatment for bleeding disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patients (18 years or greater)
- On extracorporeal membrane oxygenation
- Major bleeding defined by CTCAE class 3 or greater
- Off systemic anticoagulation for at least 4 hours
You likely can't join if
- Platelet count less than 40 x 109/L
- International normalized ratio\> 2.0
- Fibrinogen less than 150 mg/dL
- Current participation in another clinical trial (treatment)
- Heparin induced thrombocytopenia (active)
- Acute liver failure, as indicated by bilirubin \>20 mg/dL or new onset hepatic encephalopathy
See the full eligibility criteria
- Adult patients (18 years or greater)
- On extracorporeal membrane oxygenation
- Major bleeding defined by CTCAE class 3 or greater
- Off systemic anticoagulation for at least 4 hours
- Platelet count less than 40 x 109/L
- International normalized ratio\> 2.0
- Fibrinogen less than 150 mg/dL
- Current participation in another clinical trial (treatment)
- Heparin induced thrombocytopenia (active)
- Acute liver failure, as indicated by bilirubin \>20 mg/dL or new onset hepatic encephalopathy
- Patient or legally authorized representative unable to give informed consent
- Allergy to recombinant von Willebrand Factor or any component of the product based on prior exposure
- 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
- Known congenital or acquired thrombophilia
- 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...
- History of hypersensitivity to vWF concentrate
- Known history of vWF antibodies
The study team makes the final eligibility decision.
Where it's taking place
- Charlottesville, Virginia, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.