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Spray-on drug may cut blood loss in major spine surgery

NCT ID NCT03553186

Disease control Sponsor: Hospital for Special Surgery, New York 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether applying tranexamic acid directly into the surgical wound, in addition to giving it through an IV, can reduce bleeding and the need for blood transfusions in adults having extensive spine surgery. About 100 adults aged 18 to 80 with spinal deformity will take part. The goal is to see if this simple, low-cost approach makes surgery safer and speeds recovery.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 100 people

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

Started

Jul 2018

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.

Ages

18 to 80 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 18-80 * Scheduled to undergo posterior long segment ( ≥ 5 levels) posterior spinal fusion for adult scoliosis or degenerative joint diseae * \+ fusion to pelvis Exclusion Criteria: * Surgical factors: * Anterior Approach * Presence or history of dural tear without repair as evidenced by pseudomeningocele on MRI imaging or by intraoperative exploration * Patients donating autologous blood preoperatively Patient factors: * Diagnosis of renal (Cr\>1.5 or CrCl \<30ml/min) or hepatic insufficiency (AST, ALT 2x upper limit of normal) * Diagnosis of seizure disorder or prior seizure * History of thromboembolic events (CVA, TIA, DVT, PE) if within 1 year of surgery * Hypercoagulability (e.g. antiphospholipid syndrome) * History of coronary artery disease (stent, MI, +stress test) within 1 year of surgery * Atrial fibrillation * Concurrent anticoagulation therapy that cannot be discontinued within 3 days before surgery (Coumadin, plavix, LVX) * Concurrent anticoagulation with ASA 325 that cannot be discontinued 10 days before surgery * Bleeding disorder or abnormal preoperative coagulation profile (as identified by a preoperative platelet count of \<100,000/mm3, an international normalized ratio of \>1.4, or a prolonged partial thromboplastin time \>1.4 times normal) * Preexisting anemia \<10 g/dL * Color blindness or disturbance of color vision * Leukemia or active cancer * Religious restrictions on blood transfusion * Pregnancy or women who are lactating/breastfeeding

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Conditions

The condition(s) this trial relates to.

Blood Loss, Surgical lumbar spinal stenosis osteoarthritis scoliosis

As listed by the trial registrant

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

Blood loss, surgical Degenerative lumbar spinal stenosis Spinal deformity

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

  • Hospital for Special Surgery

    RECRUITING

    New York, New York, 10021, United States

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