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Can a 5-Minute blood test save trauma patients from unnecessary treatment?

NCT ID NCT07097337

Knowledge-focused Sponsor: Erasmus Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 at whether a quick bedside test can measure fibrinogen levels in trauma patients with severe bleeding within minutes, instead of the usual 30-45 minutes. Fibrinogen helps blood clot, and low levels can worsen bleeding. The test is being checked for feasibility and whether it could help doctors decide who really needs fibrinogen replacement. About 150 adults with major trauma will be enrolled, and no treatment decisions will be based on the test results yet.

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 150 people

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

Started

Nov 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

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.

Who is studied

All trauma patients for which the massive transfusion protocol has been activated and transfusion has been initiated.

Ages

16 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.

Population (base) Adult trauma patients will be identified as follows: (1) by the trauma team leader on admission to the ED or (2) by the research team personnel following a massive transfusion protocol activation. Patients will be assessed for eligibility to enter the trial according to the criteria set out below. If patients are eligible for entry into the study following initial screening, they will be enrolled automatically under deferred consent. Patients will be considered eligible for enrolment in this trial if they fulfil all the inclusion criteria and none of the exclusion criteria detailed below. Inclusion criteria To be eligible to participate in this study, a subject must meet the following criteria: * The participant is judged to be an adult (according to the attending clinician, e.g. 16 years or older) and has sustained traumatic injury * The participant is deemed by the attending clinician to have on-going active hemorrhage * The major hemorrhage protocol (MTP) is activated or this patient and transfusion is initiated Exclusion criteria * A potential subject who meets any of the following criteria will be excluded from participation in this study: * The participant has been transferred from another hospital * The trauma team leader deems the injuries incompatible with life

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Conditions

The condition(s) this trial relates to.

acquired coagulation factor deficiency blood coagulation disease congenital afibrinogenemia congenital fibrinogen deficiency

As listed by the trial registrant

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

Fibrinogen deficiency Fibrinogen; deficiency, acquired Massive hemorrhage Massive transfusion protocol Trauma coagulopathy Trauma induced coagulopathy

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

  • Erasmus Medical Center

    RECRUITING

    Rotterdam, South Holland, 3015 GD, Netherlands

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