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Coagulation Factor Replacement

Recombinant Von Willebrand Factor + Tranexamic Acid for Postpartum Hemorrhage

Phase 3
Recruiting
Led By Nicoletta Machin, DO
Research Sponsored by Nicoletta C Machin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willing to keep a diary for 3 weeks of postpartum bleeding by pictorial assessment chart (PBAC) and any blood products, transfusion, or medications taken
Pregnant females >= 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 21 days
Awards & highlights

Study Summary

This trial is testing whether a recombinant von Willebrand factor can prevent postpartum hemorrhage in women with von Willebrand disease.

Who is the study for?
The VWD-WOMAN Trial is for pregnant women over 18 with Von Willebrand Disease (VWF:RCo <0.50 IU/ml) and a history of bleeding, willing to undergo treatment at delivery/postpartum and track bleeding for 3 weeks. Excluded are those with thrombosis, heart issues, low platelets, recent surgery, other bleeding disorders or allergies to the study drugs.Check my eligibility
What is being tested?
This trial tests if recombinant Von Willebrand factor alone or combined with Tranexamic Acid can prevent postpartum hemorrhage in women with VWD. It's randomized and measures blood loss at delivery plus safety factors like transfusions and clotting up to 21 days after birth.See study design
What are the potential side effects?
Potential side effects include reactions to recombinant Von Willebrand factor or Tranexamic Acid such as allergic responses. There's also a risk of clotting due to the treatments' effect on blood coagulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to track my postpartum bleeding and any related treatments for 3 weeks.
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I am pregnant and 18 years or older.
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I have von Willebrand disease with a history of bleeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Obstetric Delivery
Secondary outcome measures
Concentration of von Willebrand factor
Number of blood products used
Volume of lochia blood loss

Trial Design

2Treatment groups
Active Control
Group I: rVWF plus TAActive Control2 Interventions
Subjects randomized to this arm will receive recombinant von Willebrand factor 80 IU/kg IV within 5-10 minutes of delivery (or epidural anesthesia) plus Tranexamic Acid 1 gm IV within 3 hours of delivery; and recombinant Von Willebrand factor 80 IU/kg on day 1 and day 2 postpartum.
Group II: rVWF aloneActive Control1 Intervention
Subjects randomized to this arm will receive recombinant von Willebrand factor 80 IU/kg IV within 5-10 minutes of delivery (or epidural anesthesia); and recombinant Von Willebrand factor 80 IU/kg on day 1 and day 2 postpartum.

Find a Location

Who is running the clinical trial?

Nicoletta C MachinLead Sponsor
Margaret RagniLead Sponsor
6 Previous Clinical Trials
48 Total Patients Enrolled
Nicoletta Machin, DOPrincipal InvestigatorUniversity of Pittsburgh

Media Library

Recombinant Von Willebrand factor (Coagulation Factor Replacement) Clinical Trial Eligibility Overview. Trial Name: NCT04344860 — Phase 3
Von Willebrand Disease Research Study Groups: rVWF plus TA, rVWF alone
Von Willebrand Disease Clinical Trial 2023: Recombinant Von Willebrand factor Highlights & Side Effects. Trial Name: NCT04344860 — Phase 3
Recombinant Von Willebrand factor (Coagulation Factor Replacement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04344860 — Phase 3

Frequently Asked Questions

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

How many people are joining this clinical trial?

"Yes, this is an ongoing study that was originally posted on June 4th, 2021. The most recent update to the listing was on July 5th, 2022. So far, 20 people have signed up at the 2 available locations."

Answered by AI

Has this medication been tested in other scientific trials without being combined with other drugs?

"At this moment, 72 clinical trials that focus exclusively on rVWF are ongoing. Out of these research projects, 32 have reached Phase 3. Most of the tests for rVWF are being conducted in Kaohsiung City, Yanchao District; however, there are a total of 391 locations worldwide where these trials are taking place."

Answered by AI

Are we still recruiting for this research project?

"This research study is still recruiting patients, as indicated by the most recent update on clinicaltrials.gov. The trial was originally posted over a year ago on June 4th, 2021."

Answered by AI

Why is rVWF treatment given by itself and not with other drugs?

"rVWF is most commonly used in the treatment of hyperfibrinolysis, but can also be helpful for patients experiencing hemorrhagic episodes, von willebrand disease, and other bleeding disorders."

Answered by AI

Is it dangerous to take rVWF by itself?

"rVWF has been studied in multiple Phase 3 trials, so there is a wealth of safety data. This gives rVWF a score of 3."

Answered by AI
~2 spots leftby Aug 2024