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New surgical powder may cut bleeding after major spine surgery

NCT ID NCT05323448

Disease control Sponsor: Polyclinique Bordeaux Nord Aquitaine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether a powder called ARISTA-AH can help stop bleeding after long-segment spinal fusion surgery. 91 patients were split into two groups: one got standard care to control bleeding, and the other got standard care plus ARISTA-AH powder applied before closing the wound. The main goal was to measure blood loss in the first 24 hours after surgery.

What this could mean

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

Active substance
ARISTA-AH (a plant-based powder applied during surgery to help stop bleeding)
What this could lead to
If it works, this could give surgeons a better tool to reduce bleeding after complex spinal surgery, potentially lowering complications and speeding recovery.
What could go wrong
This is a small, completed study with 91 patients, so results may not apply to everyone. The powder is only for use during surgery and does not treat the underlying spine condition.

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

91 people

The number who actually took part.

Started

Oct 2022

Finished

Jul 2025

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: 1. Patient eligible to a posterior lumbar or thoraco-lumbar long-segment spinal fusion. 2. Surgery targeting at least 5 adjacent vertebra combined with one of the following procedure: 1. Intersomatic bone graft; 2. Pedicle substraction osteotomy; 3. Any other intervertebral osteotomy (e.g. Smith-Petersen osteotomy); 3. The use of a surgical drain inserted at the operative site is mandatory (suction drain and other drain are eligible); Exclusion Criteria: 1. Subject under the age of 18 years old; 2. Subject with a known haemostatic disorder; 3. Subject with any infection or any immune system disorder; 4. Subject not eligible to a posterior spinal surgery; 5. Subject with a known allergy or any contraindication to the use of the study device; 6. Currently pregnant or planning pregnancy; 7. Prisoner or a ward of the state; 8. Subject no willing to participate in the study; 9. Subject not affiliated to a social security insurance.

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As listed by the trial registrant

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

Hemostasis Hemostatics Spinal deformity Spinal fusion

Contacts and locations

Locations

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33077, France

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