Actively Recruiting
Study on Ketorolac for Improving Outcomes and Prognosis in Patients With Stanford Type A Aortic Dissection
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2025-11-17
360
Participants Needed
1
Research Sites
148 weeks
Total Duration
On this page
Sponsors
T
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead Sponsor
G
Guangdong Provincial People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study on Ketorolac for Improving Outcomes and Prognosis in Patients With Stanford Type A Aortic Dissection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with Stanford Type A aortic dissection confirmed by imaging and scheduled for emergency surgery.
- Age between 18 and 65 years.
- Signed informed consent to participate in the study.
You will not qualify if you...
- Unable to eat independently or require prolonged fasting.
- History of malignant tumors.
- Body weight less than 50 kg.
- Traumatic aortic dissection.
- Diagnosis of Marfan syndrome.
- Unstable vital signs requiring preoperative mechanical support or resuscitation (e.g., IABP, ECMO, LVAD).
- Need for preoperative endotracheal intubation.
- Consciousness impairment, central nervous system dysfunction, or cerebral malperfusion syndrome on admission.
- Preoperative hematemesis, melena, fresh blood in stool, or bowel dilation symptoms.
- Clear evidence of limb malperfusion before surgery.
- Presence of organ malperfusion syndrome.
- Requirement of 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 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 or decline informed consent.
- Any other conditions deemed unsuitable for participation by the investigator.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210008
Actively Recruiting
Research Team
T
Tuo Pan, MD
CONTACT
D
Dongjin Wang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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