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Recruiting Phase 3 NCT06968806

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

Trial Parameters

Condition Aortic Dissection
Sponsor The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 360
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2025-10-27
Completion 2027-09-01
Interventions
Ketorolac0.9 % saline

Brief 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.

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 proce

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