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New clotting drug may cut bleeding risk in rare cancer surgery

NCT ID NCT06617897

Disease control Sponsor: CSL Behring Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a concentrated clotting drug (fibrinogen) can better control major blood loss during surgery for pseudomyxoma peritonei, a rare abdominal cancer. About 90 adults will be randomly assigned to receive either the drug or a standard blood product during their operation. The goal is to see if the drug reduces the need for blood transfusions and improves surgical outcomes.

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

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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

Anyone

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: * • Aged \>= 18 years at the time of providing written informed consent. * • Diagnosis of PMP requiring CRS with HIPEC. * • Bleeding risk: Predicted intraoperative blood loss of \>=2L, assessed within 60 and 100 mins after start of study surgery (assessment made before 2 L of blood is lost) Exclusion Criteria: * • Confirmed or suspected congenital or acquired coagulation disorder or a prothrombotic disorder * • Myocardial infarction, acute coronary syndrome, or stroke within 2 months before study surgery. * • Known history of chronic hepatitis. * • Clopidogrel or ticagrelor administration within 5 days before study surgery. * • Prasugrel administration within 7 days before study surgery. * • Oral factor Xa inhibitor administration within 2 days before study surgery. * • Glycoprotein IIb / IIIa antagonist administration within 24 hours before study surgery. * • Oral direct thrombin inhibitor administration within 3 days before study surgery. * • Vitamin K antagonists within 5 days before study surgery.

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Conditions

The condition(s) this trial relates to.

acquired coagulation factor deficiency blood coagulation disease congenital afibrinogenemia pseudomyxoma peritonei

As listed by the trial registrant

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

Acquired fibrinogen deficiency

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Basingstoke and North Hampshire Hospital

    RECRUITING

    Basingstoke, RG24 9NA, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.