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Could a simple drug shield organs after aortic tear surgery?

NCT ID NCT07156656

Disease control Sponsor: Shanghai Zhongshan Hospital 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether a drug called sivelestat sodium can reduce organ damage in people who have emergency surgery for a torn aorta (type A aortic dissection). About 236 patients will receive either the drug or a placebo for 3 days after surgery. The main goal is to see if the drug improves a score that measures how well multiple organs are working.

What this could mean

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

Active substance
sivelestat sodium
What this could lead to
If it works, this could point toward a new way to protect organs after major heart surgery, potentially reducing complications and improving recovery.
What could go wrong
This is a relatively small, early-phase 4 trial. The drug may not show a meaningful benefit over standard care, and there is always a risk of side effects like allergic reactions or bleeding.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 236 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Sep 2028

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 75 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: 1. Age 18-75 years inclusive. 2. Written informed consent obtained before participation. 3. Confirmed acute Stanford type A aortic dissection scheduled for surgical repair. Exclusion Criteria: 1. Life expectancy ≤ 48 hours. 2. Pregnant or lactation. 3. Severe pre-operative liver dysfunction: Child-Turcotte-Pugh score 10-15. 4. Severe pre-operative renal dysfunction: acute or chronic kidney injury meeting criteria for renal-replacement therapy. 5. Confirmed COPD or asthma. 6. Immunosuppression: long-term or \> 2 weeks continuous systemic corticosteroids. 7. Concomitant or anticipated use of immunomodulators (Xue-Bi-Jing injection, thymosin, IVIG). 8. Medical or psychological condition that would interfere with study participation, assessment, or outcomes.

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Conditions

The condition(s) this trial relates to.

familial thoracic aortic aneurysm and aortic dissection multiple organ dysfunction syndrome

As listed by the trial registrant

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

Organ failure, multiple Type A aortic dissection

How to take part

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

  1. The places running it

    6 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

  • Changhai Hospital of Shanghai

    Shanghai, Shanghai Municipality, China

  • Fujian Provincial Hospital

    Fuzhou, Fujian, China

  • Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences) (Guangdong Provincial People's Hospital Affiliated to Southern Medical University)

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, China

  • The First Affiliated Hospital of Xi'an Jiao Tong University

    Xi'an, Shaanxi, China

  • The University of Hong Kong - Shenzhen Hospital

    Shenzhen, Guangdong, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.