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New model aims to decode mysterious blood test results

NCT ID NCT07418099

Knowledge-focused Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 11, 2026 · Updated 4 times

Summary

This study is checking if a computer model can accurately predict why some people have a prolonged blood clotting time (APTT). The model uses data from routine blood tests to tell if the cause is harmless or a sign of a clotting disorder. Researchers will test it on 1,500 patients across multiple hospitals to see how well it works.

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, this model could help doctors quickly identify the cause of abnormal blood clotting test results, reducing unnecessary follow-up tests.
What could go wrong
This is an observational study, not a treatment trial. The model may not perform as well in real-world settings, and it does not directly improve patient 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.

Participants

About 1,500 people

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

Started

Jan 2026

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

The study population includes pediatric and adult patients undergoing routine coagulation testing in clinical practice who present with isolated prolongation of activated partial thromboplastin time (APTT) and normal prothrombin time (PT). Patients may be evaluated in the preoperative setting or during routine clinical care for other indications. All laboratory data, including clot waveform analysis (CWA), are generated as part of standard diagnostic procedures, without additional blood sampling or modification of clinical management. Patients receiving anticoagulant therapy that may prolong APTT are included, provided that PT remains within the normal range. The study uses pseudonymized data obtained from electronic medical records and laboratory systems, with no direct patient contact and no anticipated risks beyond routine care.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: 1. Patients of any age (pediatric and adult populations) undergoing coagulation testing with: \- Prolonged activated partial thromboplastin time (APTT), defined as an APTT ratio ≥ 1.25. \- Normal prothrombin time (PT), according to local laboratory reference ranges. 2. Availability of clot waveform analysis (CWA) data obtained during routine APTT testing using: * Optical coagulation analyzers (ACL TOP platform). * Silica-based APTT reagent (SynthASil®). 3. Completion of the standard laboratory evaluation for prolonged APTT as part of routine clinical care, when clinically indicated. 4. Samples collected and processed in accordance with the standardized preanalytical protocol defined in the study SOP. 5. Patients evaluated in either: * Preoperative assessment, or * Routine clinical practice (non-preoperative setting). Exclusion Criteria: 1. Prolonged prothrombin time (PT) or combined prolongation of PT and APTT. 2- Inadequate preanalytical conditions, defined as non-compliance with the study SOP, including but not limited to: * Incorrect blood-to-anticoagulant ratio. * Delayed plasma processing beyond protocol-defined time limits. * Inadequate centrifugation or plasma quality. 3\. Absence of required CWA data or unavailable clot waveform images. 4\. Samples in which APTT values are outside the measurable range of the analyzer, preventing extraction of CWA-derived parameters. 5- Patients with missing essential clinical or laboratory data required for application of the APTTO models.

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Conditions

The condition(s) this trial relates to.

blood coagulation disease congenital factor XII deficiency vascular hemostatic disease von Willebrand disease (hereditary or acquired)

As listed by the trial registrant

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

Coagulation disorder, blood Prolonged aptt

How to take part

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

  1. The places running it

    16 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

  • Clínica Universidad de Navarra

    RECRUITING

    Pamplona, Spain

  • Complexo Hospitalario Universitario De Vigo

    NOT_YET_RECRUITING

    Vigo, Spain

  • Complexo Hospitalario Universitario de Santiago

    RECRUITING

    Santiago de Compostela, Spain

  • Hospital Clínico Universitario Lozano Blesa

    RECRUITING

    Zaragoza, Spain

  • Hospital Clínico Universitario Virgen de la Arrixaca

    NOT_YET_RECRUITING

    Murcia, Spain

  • Hospital Clínico Universitario de Salamanca

    NOT_YET_RECRUITING

    Salamanca, Spain

  • Hospital Clínico Universitario de Valladolid

    RECRUITING

    Valladolid, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Arnau De Vilanova

    RECRUITING

    Lleida, Spain

  • Hospital Universitario Clínico San Carlos

    NOT_YET_RECRUITING

    Madrid, Spain

  • Hospital Universitario Fundación Jiménez Díaz

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Gregorio Marañón

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Puerta de Hierro

    NOT_YET_RECRUITING

    Madrid, Spain

  • Hospital Universitario Ramón y Cajal

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Severo Ochoa

    RECRUITING

    Leganés, Madrid, Spain

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, Spain

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