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Coagulation Factor Replacement

Recombinant Von Willebrand Factor + Tranexamic Acid for Postpartum Hemorrhage

Phase 3

Waitlist Available

Led By Margaret V Ragni, MD, MPH

Research Sponsored by Nicoletta C Machin

Eligibility Criteria Checklist

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

Must have

Pregnant females >= 18 years of age

Confirmed VWD, as defined by VWF:RCo < 0.50 IU/dL and previous history of bleeding

Must not have

Previous thrombosis, cardiac disease, congestive failure, arrhythmia, hypertension, MI, or stroke

Any bleeding disorder other than VWD; or past thrombotic disease of other bleeding disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 21 days

Awards & highlights

Pivotal Trial

No Placebo-Only Group

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.

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.

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 pregnant and 18 years or older.

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I have von Willebrand disease with a history of bleeding.

Exclusion Criteria

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

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I have had heart issues, including a heart attack, stroke, or blood clots.

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I do not have a bleeding disorder other than von Willebrand Disease.

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I have not had surgery in the last 8 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 21 days

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

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

Primary study objectives

Obstetric Delivery

Secondary study objectives

Concentration of von Willebrand factor

Number of blood products used

Volume of lochia blood loss

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

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.

0 / 5Eligibility criteria met