Status:
RECRUITING
Study on Ketorolac for Improving Outcomes and Prognosis in Patients With Stanford Type A Aortic Dissection
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborating Sponsors:
Guangdong Provincial People's Hospital
Huai'an First People's Hospital
Conditions:
Aortic Dissection
Inflammation
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 2...
Detailed Description
This multicenter, randomized, double-blind, controlled clinical trial will enroll 360 eligible patients with Stanford Type A aortic dissection between March 2025 and December 2027. Participants will b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT06968806
Start Date
October 27 2025
End Date
September 1 2028
Last Update
November 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210008