Ketorolac to improve outcomes and prognosis in Stanford Type A aortic dissection

Study on Ketorolac for Improving Outcomes and Prognosis in Patients With Stanford Type A Aortic Dissection -A Single-Center, Randomized, Double-Blind, Controlled Clinical Trial

This trial will test whether giving ketorolac around emergency surgery helps adults (18–65) with Stanford Type A aortic dissection recover better and have fewer complications over 90 days.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06968806 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial enrolling 360 adults with imaging-confirmed Stanford Type A aortic dissection between 2025 and 2027. Participants are randomized to receive either ketorolac (60 mg IM preoperatively then 30 mg twice daily for two days postoperatively) or matching placebo in addition to standard perioperative care. Outcomes include a composite of clinical endpoint events, postoperative complications, and adverse events, with data collected through clinical exams, laboratory testing, and imaging at predefined intervals up to 90 days. The trial will monitor safety closely and discontinue treatment/report any treatment-related serious adverse events immediately.

Who should consider this trial

Good fit: Adults aged 18–65 with imaging-confirmed Stanford Type A aortic dissection who are scheduled for emergency surgical repair, able to provide informed consent, and who do not meet the trial's exclusion criteria are the intended participants.

Not a fit: Patients with Marfan syndrome, traumatic dissection, preoperative organ or limb malperfusion, hemodynamic instability requiring mechanical support, preoperative intubation, active gastrointestinal bleeding, body weight under 50 kg, or other listed exclusions are unlikely to be eligible or to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, perioperative ketorolac could reduce postoperative complications and improve short-term (90-day) recovery and prognosis after surgery for Type A aortic dissection.

How similar studies have performed: Use of perioperative NSAIDs like ketorolac in acute Type A aortic dissection is largely novel and prior evidence from related cardiac surgery settings is limited and mixed rather than definitively successful.

Eligibility criteria

Inclusion Criteria:

* Patients with Stanford Type A aortic dissection confirmed by imaging and scheduled for emergency surgery.

Aged between 18 and 65 years.

Signed informed consent.

Exclusion Criteria:

* 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 this trial is running

Nanjing, Jiangsu

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

Study contacts

• Principal investigator: DongJin Wang, MD — The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Study coordinator: Tuo Pan, MD

Conditions Aortic Dissection; Inflammation; Ketorolac