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New combo aims to stop postpartum bleeding in bleeding disorder

NCT ID NCT04344860

Disease control Sponsor: Nicoletta C Machin Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed phase 3 trial tested whether adding tranexamic acid to recombinant von Willebrand factor (rVWF) reduces postpartum hemorrhage better than rVWF alone in 20 pregnant women with von Willebrand disease. Participants received either the combination or rVWF alone at delivery. The main goal was to measure blood loss during and after childbirth. This study aims to improve bleeding control in a high-risk group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Recombinant von Willebrand factor (rVWF) and tranexamic acid
What this could lead to
If it works, this combination could offer a better way to prevent dangerous bleeding after childbirth in women with von Willebrand disease.
What could go wrong
This is a small, single-center trial with only 20 participants, so results may not apply to everyone. The added benefit of tranexamic acid over rVWF alone is uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

20 people

The number who actually took part.

Started

Jun 2021

Finished

Sep 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Pregnant females \>= 18 years of age 2. Confirmed VWD, as defined by VWF:RCo \< 0.50 IU/dL and previous history of bleeding 3. Willingness to have blood drawn 4. Willing to be randomized to one of two treatments at delivery and for 2 days postpartum. 5. Willing to keep a diary for 3 weeks of postpartum bleeding by pictorial assessment chart (PBAC) and any blood products, transfusion, or medications taken. 6. Willing to return at 21 days for final blood draw and review of diary. Exclusion Criteria: 1. Any bleeding disorder other than VWD; or past thrombotic disease of other bleeding disorders. 2. Previous thrombosis, cardiac disease, congestive failure, arrhythmia, hypertension, MI, or stroke. 3. Platelet count \< 100,000/ ul. 4. Past allergic reaction to VWF or tranexamic acid. 5. Surgery within the past 8 weeks. 6. Inability to comply with study protocol requirements. 7. Concomitant use of antiplatelet drugs, anticoagulants, or NSAIDs. Aspirin will be allowed for preeclampsia prevention. 8. Treatment with DDAVP, cryoprecipitate, whole blood, plasma or plasma derivatives containing substantial quantities of VWF within 5 days of study. 9. History of renal disease. 10. Inability to comply with study requirements.

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Conditions

The condition(s) this trial relates to.

hereditary von Willebrand disease Postpartum Hemorrhage von Willebrand disease (hereditary or acquired)

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Postpartum hemorrhage Von Willebrand diseases

Contacts and locations

Locations

  • Hemophilia Center of Western PA

    Pittsburgh, Pennsylvania, 15213, United States

More trials for these conditions

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