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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Aortic Dissection, Inflammation

In brief

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.

Key facts

Study ID

NCT06968806

Run by

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

People needed

360

Starts

2025-10-27

Expected to finish

2028-09-01

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with Stanford Type A aortic dissection confirmed by imaging and scheduled for emergency surgery.
• Aged between 18 and 65 years.
• Signed informed consent.

You may not qualify if…

• Patients who are unable to eat independently or require prolonged fasting.
• History of malignant tumors.
• Body weight <50 kg.
• Traumatic aortic dissection.
• Patients with Marfan syndrome.
• Unstable vital signs requiring preoperative mechanical support or resuscitation (e.g., IABP [Intra-Aortic Balloon Pump], ECMO [Extracorporeal Membrane Oxygenation], LVAD [Left Ventricular Assist Device])
• Patients requiring preoperative endotracheal intubation.
• Consciousness impairment, central nervous system dysfunction, or evidence of cerebral malperfusion syndrome upon admission.
• Preoperative hematemesis, melena, fresh blood in stool, or symptoms of bowel dilation.
• Clear evidence of limb malperfusion before surgery.
• Presence of organ malperfusion syndrome.
• Patients requiring interventional procedures to relieve organ malperfusion before surgery.
• History of gastrointestinal ulcers or chronic gastrointestinal inflammatory diseases.
• History of dialysis or renal insufficiency before admission.
• History of liver disease.
• Allergy to ketorolac tromethamine, aspirin, or other nonsteroidal anti-inflammatory drugs (NSAIDs).
• Chronic inflammatory diseases, autoimmune diseases, or long-term use of steroids or NSAIDs for other reasons.
• Absence of cerebral perfusion during deep hypothermic circulatory arrest.
• History of major surgery or acute myocardial infarction within 90 days.
• History of cardiac or major vascular surgery.
• Pregnant or lactating women.
• Patients who refuse to participate in this clinical trial or decline to sign the informed consent form.
• Any other conditions deemed unsuitable for participation by the investigator.

Where it is running

• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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