Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Beijing Anzhen Hospital | OTHER |
| West China Hospital | OTHER |
| Shanghai East Hospital of Tongji University | OTHER |
| The First Affiliated Hospital of Guangzhou Medical University |
Not provided
Not provided
Not provided
Not provided
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 in addition to antiinflammatory treatment may be beneficial. This study was designed to test the hypothesis that the administration of Ulinastatin and Thymosin α1 during the acute phase of AAS will result in a reduced incidence of SIRS and MODS.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UT Group | Experimental | Ulinastatin (100000U TID for 5 days) and Thymosin alpha 1 (1.6 mg q12h for 5 days) immediately after surgery |
|
| Control Group | Active Comparator | Ulinastatin (100000U TID for 5 days) immediately after surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ulinastatin and Thymosin α1 | Drug | Ulinastatin (100000U TID for 5 days) and Thymosin alpha 1 (1.6 mg q12h for 5 days) immediately after surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| The mean Sequential Organ Failure Assessment (SOFA) score of 7 days after surgery | The occurrence of new-onset organ failure and new-onset persistent organ failure (Sequential Organ Failure Assessment (SOFA) score. New-onset is defined as events that occur after randomization and not present 24 hours before randomization. | within the prior 7 days after surgery. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yong-feng Shao | The First Affiliated Hospital with Nanjing Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital | Beijing | Beijing Municipality | China | |||
| The First Affiliated Hospital of Guangzhou Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28069319 | Result | Liu D, Yu Z, Yin J, Chen Y, Zhang H, Xin F, Fu H, Wan B. Effect of ulinastatin combined with thymosin alpha1 on sepsis: A systematic review and meta-analysis of Chinese and Indian patients. J Crit Care. 2017 Jun;39:259-266. doi: 10.1016/j.jcrc.2016.12.013. Epub 2016 Dec 27. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
| Ulinastatin only | Drug | Ulinastatin (100000U TID for 5 days) immediately after surgery |
|
| Guangzhou |
| Guangdong |
| China |
| Shanghai East Hospital Tongji University | Shanghai | Shanghai Municipality | China |
| West China Hospital | Chengdu | Sichuan | China |
| ID | Term |
|---|---|
| D000784 | Aortic Dissection |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D000094665 | Dissection, Blood Vessel |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000094683 | Acute Aortic Syndrome |
| D001018 | Aortic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C028665 | urinastatin |
Not provided
Not provided
Not provided