AI-assisted Subtyping-directed Precision Treatment in Acute Aortic Dissection

What Was Tested

This registered not phased trial tested Thymosin Alpha-1.

Aortic dissection has acute onset and high mortality, with immunoinflammatory response driving lesion progression.

Current perioperative anti-inflammatory therapies are mostly empirical and poorly targeted, and AI-assisted typing lacks a complete clinical translation pathway.

This study integrates multi-dimensional data to construct an AI immunoinflammatory subtyping system, enabling rapid subtyping and establishing a "subtyping-target-treatment" closed loop for emergency needs.

It had two arms (groups): Subtyping-based precision therapy (experimental) and Conventional Empirical Strategy (active comparator).

* Balanced type (HIS1): No anti-inflammatory intervention required; * Inflammation-excessive type (HIS2): Anti-inflammatory intervention with ulinastatin; ③ Immunosuppressive type (HIS3): Immunomodulation with thymalfasin; ④ Mixed reaction type (HIS4): Combined treatment with ulinastatin and thymalfasin.

Treatment of physician's choice alone.

The registry classes the interventions as drug.

Who Took Part

300 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Confirmed diagnosis of acute aortic dissection by contrast-enhanced Computed Tomography Angiography (CTA) or Magnetic Resonance Angiography (MRA);. Planned emergency surgical treatment (including open surgery and endovascular repair);. Aged 18-80 years old, regardless of gender;. Signed informed consent form by the patient or their authorized agent, with willingness to cooperate with the follow-up of the study.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: long-term use of immunosuppressants or glucocorticoids before surgery (continuous use for ≥ 2 weeks);; pregnant or lactating women;; patients with mental disorders or cognitive dysfunction who cannot cooperate with the study.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Thymosin Alpha-1 and who got the comparison, which limits bias.

The Thymosin Alpha-1 group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Thymosin Alpha-1, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2027-12-31 with completion listed for 2027-12-31.

It ran at 8 sites in China (8).

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Sequential Organ Failure Assessment (SOFA) score. The SOFA score evaluates 6 organ systems, ranging from 0, no dysfunction, to 4, failure, and the total score ranges from 0, normal, to 24, most severe form of multiorgan failure (time frame: 7 days after surgery).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Thymosin Alpha-1 in 300 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Thymosin Alpha-1 compound page, all human trials.