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New study tests bleeding drug for Kids' spine surgery

NCT ID NCT07581457

Disease control Sponsor: Poznan University of Medical Sciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Updated 2 times

Summary

This study tests if tranexamic acid (TXA), a drug that reduces bleeding, is safe and effective for children aged 10-18 having surgery for idiopathic scoliosis. Participants are randomly assigned to one of two TXA dosing regimens or a placebo. The main goal is to measure total blood loss and the need for blood transfusions during and after surgery. The study is double-blind, meaning neither patients nor doctors know who gets TXA or placebo.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 90 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 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.

Ages

10 to 18 years

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: * Age 10 to 18 years * Diagnosis of idiopathic scoliosis requiring surgical correction (posterior spinal fusion) * American Society of Anesthesiologists (ASA) physical status I-II * Written informed consent from parents or legal guardians and assent from the child Exclusion Criteria: * Congenital or acquired coagulopathy * History of thromboembolic disease * History of seizures or epilepsy * Known hypersensitivity to tranexamic acid * Renal insufficiency (estimated glomerular filtration rate \< 60 mL/min/1.73 m²) * Cardiac arrhythmias or cardiovascular disease requiring antiplatelet or anticoagulant therapy

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Conditions

The condition(s) this trial relates to.

adolescent idiopathic scoliosis idiopathic scoliosis scoliosis

As listed by the trial registrant

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

Scoliosis idiopathic Scoliosis; adolescence

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

  • Poznan University of Medical Sciences

    RECRUITING

    Poznan, 62-701, Poland

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