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AI takes on blood clotting tests: could it outsmart the experts?

NCT ID NCT07502950

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will compare how well an artificial intelligence (AI) system and human experts interpret ROTEM tests, which measure blood clotting in patients undergoing surgery or in critical care. Researchers will enroll 400 adults and assess agreement on whether a clotting problem exists, what type it is, and what treatment to give. The goal is to see if AI can provide reliable, fast decision support to reduce variability in clinical practice.

What this could mean

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

What this could lead to
If successful, AI could help doctors interpret blood clotting tests faster and more consistently, potentially improving care for patients in surgery or intensive care.
What could go wrong
This is an early observational study, not a treatment trial. AI may not match expert judgment in all cases, and real-world use would require further validation.

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 400 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jul 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

The study population will consist of adult patients undergoing rotational thromboelastometry (ROTEM) as part of routine clinical care in participating centers. Patients will be recruited from perioperative and intensive care settings, including major surgery, trauma, and critical illness, where assessment of coagulation status is clinically indicated. This study reflects real-world practice, with no modification of standard care. The unit of analysis will be individual ROTEM measurements rather than individual patients, as repeated measurements may occur during clinical management. Only ROTEM datasets with complete graphical and numerical outputs and meeting predefined quality criteria will be included.

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: Adult patients (age ≥18 years) * ROTEM analysis performed using a ROTEM Sigma device as part of routine clinical care * Availability of complete ROTEM output (graphical and numerical data) * ROTEM measurement obtained in a clinical context where assessment of coagulation status is indicated (e.g., perioperative setting, trauma, or critical illness) Exclusion Criteria: * ROTEM measurements performed using the HEPTEM channel * Incomplete or missing ROTEM data preventing standardized evaluation * ROTEM measurements obtained under non-standardized or technically unreliable conditions

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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  2. A doctor treating you

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