Acute Aortic Syndrome, Aortic Dissection Type A
Conditions
Brief summary
Systemic inflammatory response syndrome (SIRS) and multiple organ dysfunction syndrome (MODS) are the major causes of death in patients with acute aortic syndrome (AAS). Therefore, the prevention of SIRS and MODS is of great clinical value, and immunomodulatory therapy with thymosin alpha 1 may be beneficial. This study was designed to test the hypothesis that the administration of thymosin alpha 1 during the acute phase of AAS will result in a reduced incidence of SIRS and MODS.
Interventions
DRUGThymosin Alpha1, 28A-Glycine-28B-L-Arginine-28C-L-Glutamic Acid-28D-L-Alanine-28E-L-Proline-28F-L-Alanine-28G-L-Asparagine-
Thymosin alpha 1, 1.6mg injection hypodermic (I.H), every 12 hours for 5 days at least during the ICU admission. The administration will be terminated any day during the treatment when the patient is deemed as qualified for ICU discharge or dead.
DRUGBlank control
Blank control (Standard care control; no placebo or sham thymosin alpha 1 injections were administered.)
Sponsors
Nanjing Medical University
Beijing Anzhen Hospital
Second Affiliated Hospital of Nanchang University
Qilu Hospital of Shandong University
The First Affiliated Hospital of Guangzhou Medical University
Northern Jiangsu People's Hospital
Guangdong Provincial People's Hospital
First Affiliated Hospital of Kunming Medical University
Nanjing First Hospital, Nanjing Medical University
Shanghai East Hospital of Tongji University
The Seventh Affiliated Hospital of Xinjiang Medical University
TEDA International Cardiovascular Hospital
The First Affiliated Hospital of Bengbu Medical University
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
Masking was role specific. Participants were not informed of treatment allocation. Treating ICU physicians were not involved in randomization or study-drug prescription but could potentially ascertain allocation from electronic medication records and were therefore not considered formally masked. Nursing personnel were not uniformly masked. Independent SOFA outcome assessors were unaware of treatment allocation. Flow-cytometry and biomarker personnel and statisticians were also unaware of allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* The patients are conformed to 2010 ACC/AHA guidelines for the diagnosis and treatment of thoracic aortic disease (TAD) within two weeks of onset; * Patients with acute aortic syndrome confirmed clinically and radiologically and planning to undergo emergency surgery were enrolled. * The patients' age between 18 \~90 years old. * Agree to participate in the study and sign the informed consent.
Exclusion criteria
* Patients allergic to Thymosin α1; * Lactating women and pregnant women; * Patients with mental diseases, drug and alcohol dependence; * Refuse to participate in this study and refuse to sign the informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-day postoperative organ dysfunction burden assessed by mean daily SOFA score | 7 days after surgery | The primary outcome is early postoperative organ dysfunction burden, quantified as the mean daily Sequential Organ Failure Assessment (SOFA) score over postoperative days 1-7 using a fixed 7-day assessment window. Higher scores indicate greater organ dys |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-day mortality | 30 days after randomization | Death from any cause of 30 days after randomization |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORHong Liu
Nanjing Medical University
Outcome results
None listed