Study on Ketorolac for Improving Outcomes and Prognosis in Patients With Stanford Type A Aortic Dissection

Summary

This multicenter, randomized, double-blind, placebo-controlled trial evaluates the efficacy and safety of ketorolac in 360 patients with Stanford Type A aortic dissection, conducted between 2025 and 2027. Participants will receive either ketorolac (60 mg intramuscularly \[IM\] preoperatively and 30 mg twice daily \[BID\] for two days postoperatively) or placebo in addition to standard care. Study outcomes include composite clinical endpoints, postoperative complications, and adverse events, which will be assessed through clinical evaluations, laboratory testing, and imaging studies at predefined intervals up to 90 days. The objective of this trial is to determine whether perioperative administration of ketorolac improves clinical outcomes in this patient population.

Conditions

• Aortic Dissection
• Inflammation

Interventions

DRUG

Ketorolac

patients in the experimental group will receive ketorolac treatment for Stanford Type A aortic dissection, consisting of a 60mg intramuscular injection preoperatively followed by 30mg twice daily for two days postoperatively, while maintaining standard baseline therapies including analgesia, blood pressure control, and subsequent cardiovascular surgical management.

DRUG

0.9 % saline

0.9% saline

Sponsors & Collaborators

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Huai'an First People's Hospital

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• The Second Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• THE FIRST AFFILIATED HOSPITAL OF SHIHEZI UNIVERSITY

  collaborator UNKNOWN

• Xinhua Hospital of Ili Kazak Autonomous Prefecture

  collaborator UNKNOWN

• Henan Provincial Chest Hospital

  collaborator OTHER

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  lead OTHER

Principal Investigators

• Tuo Pan, MD · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

• DongJin Wang, MD · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

• DongJin Wang, MD · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-27

Primary Completion

2027-09-01

Completion

2028-09-01

Countries

• China

Study Locations