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Can a simple drug cut blood loss in spine surgery?

NCT ID NCT03849443

Disease control Sponsor: Rush University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 giving multiple doses of tranexamic acid (TXA) by mouth or through a vein can reduce blood loss and the need for blood transfusions after spine surgery. It involves 604 adults scheduled for open back surgery who are at high risk for needing a transfusion. The goal is to find the best way to give TXA to improve recovery and safety.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 604 people

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

Started

Aug 2019

Expected to finish

Jan 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

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: * Any patient older than 18 years old * Scheduled for an open posterior thoracolumbar spinal fusion procedure Exclusion Criteria: * Allergy to TXA * Acquired disturbances of color vision * Refusal of blood products * Pre-op use of anticoagulant therapy within five days before surgery * History of arterial or venous thromboembolic disease (such as DVT, PE, CVA, TIA) * Pregnancy * Breastfeeding * Severe ischemic heart disease \[New York Heart Association Class III or IV\] * Previous myocardial infarction * Severe pulmonary disease * Renal impairment * Hepatic failure * Patients who decline to participate * Intolerance or sensitivity to Vitamin C

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As listed by the trial registrant

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

Open posterior thoracolumbar spinal fusion procedure

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

  • Rush University Medical Center

    RECRUITING

    Chicago, Illinois, 6060712, United States