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Tiny study aims to find safer clotting drugs for trauma patients

NCT ID NCT07290634

Knowledge-focused Sponsor: Zeliha Alicikus 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks back at medical records of 4 severely injured trauma patients who needed large blood transfusions. It compares two drugs that help blood clot—prothrombin complex concentrate and recombinant activated factor VIIa—to see which causes fewer dangerous blood clots and other complications. The goal is to learn which drug might be safer for these critically ill patients.

What this could mean

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

Active substance
Prothrombin complex concentrate and recombinant activated factor VIIa
What this could lead to
If successful, this could help doctors choose the safest blood-clotting drug for trauma patients needing massive transfusions, potentially reducing complications.
What could go wrong
This is a very small, early retrospective study with only 4 participants, so results may not apply broadly. The study only observes past events, so it cannot prove cause and effect.

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.

Participants

About 4 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Who is studied

This will be a retrospective cohort study conducted between 1 January 2023 to 1 October 2025 at University of Florida Jacksonville trauma center. The study will evaluate the impact of Prothrombin Complex, recombinant activated factor VII, and their combination on outcomes in adult trauma patients undergoing massive transfusion.

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: * Adults ≥18 years * Trauma patients directly admitted from the scene with highest-level trauma activation: Injury -Severity Score (ISS) \>15. * Requirement for massive transfusion, defined as ≥3 units packed red blood cells (PRBC) within the first hour or ≥10 PRBC within the first 24 hours Exclusion Criteria: * Traumatic cardiac injury * Death anticipated within the first hour of admission: ISS score \>49 * Pre-injury anticoagulant therapy * Known pregnancy * Pre-injury terminal illness

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Conditions

The condition(s) this trial relates to.

injury thrombocytopenia Thromboembolism

As listed by the trial registrant

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

Massive blood transfusion; thrombocytopenia Thromboembolus Trauma

How to take part

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

  1. The places running it

    2 sites. 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

  • UF Health Jacksonville (Shands Hospital)

    RECRUITING

    Jacksonville, Florida, 32209, United States

  • UF Health Jacksonville (Shands Hospital)

    RECRUITING

    Jacksonville, Florida, 32218, United States

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