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

Launched by THE AFFILIATED NANJING DRUM TOWER HOSPITAL OF NANJING UNIVERSITY MEDICAL SCHOOL · May 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called ketorolac to see if it can help improve the recovery and overall health of patients with a serious condition known as Stanford Type A aortic dissection, which involves a tear in the main artery coming from the heart. The trial will include around 360 patients who are scheduled for emergency surgery. Participants will either receive ketorolac or a placebo (a substance with no active medication) along with their normal care. The researchers will monitor participants for up to 90 days after surgery to check for any complications or side effects and to see if ketorolac makes a difference in recovery.

To be eligible for this trial, patients need to be between 18 and 65 years old and must have a confirmed diagnosis of Stanford Type A aortic dissection that requires emergency surgery. However, there are certain conditions that may exclude someone from participating, such as severe health issues or previous surgeries that could complicate their care. If chosen to participate, patients can expect to receive either the study drug or a placebo along with standard medical treatment, and they will be closely monitored throughout their recovery. This trial aims to determine if using ketorolac around the time of surgery can lead to better outcomes for patients facing this critical condition.

Gender

ALL

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.