Ketorolac to improve outcomes and prognosis in Stanford Type A aortic dissection
Official title: Efficacy and Safety of Ketorolac in Improving Prognosis of Stanford Type A Aortic Dissection: a Multicenter, Randomised, Double-blind, Controlled Clinical Trial
Run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · NCT06968806 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 1346 (estimated) |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Status | Recruiting |
| Started | October 27, 2025 |
| Main results expected | September 1, 2027 |
| Study ends | December 1, 2028 |
| Registry record updated | August 31, 2026 |
| Trial ID | NCT06968806 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria The criteria for inclusion are: (1) Imaging diagnosis of ATAAD and planning for emergency surgery; (2) Age between 18 and 65 years; (3) Signed informed consent; (4) First median sternotomy; (5) Duration from symptom onset to surgery less than or equal to 7 days; (6) Preoperative data are complete; (7) Glasgow Coma Scale (GCS) score greater than or equal to 15, with no new focal neurological deficits. Exclusion criteria The criteria for exclusion include: (1) Extended periods of fasting or inability to feed oneself; (2) A history of cancer; (3) Weight below 50 kg; (4) Traumatic dissections of the aorta; (5) Individuals diagnosed with Marfan syndrome; (6) Preoperative vital sign instability necessitating mechanical assistance or resuscitation ; (7) The duration of preoperative tracheal intubation exceeds 3 days. (8) Disorders of consciousness, central nervous system issues, or signs of inadequate brain perfusion after admission; (9) Preoperative gastrointestinal involvement and intestinal dilation； (10) Clear signs of inadequate limb perfusion before the procedure; (11) Presence of organ perfusion insufficiency syndrome; (12) Patients needing preliminary surgical intervention to address organ perfusion issues; (13) A history of gastrointestinal ulcers or chronic inflammation of the gastrointestinal tract;;(14) Preoperative hepatic and renal dysfunction;(15) Allergies to ketorolac tromethamine, aspirin, or other NSAIDs; (16) Chronic inflammatory or autoimmune conditions requiring long-term hormone or NSAID use; (17) Absence of brain perfusion during deep hypothermic circulatory arrest; (18) A history of grade IV surgery or acute myocardial infarction within the last 90 days; (19) Previous cardiac or major vascular surgeries; (20) Pregnant or breastfeeding women; (21) Cardiopulmonary bypass (CPB) lasting over 4 hours, deep hypothermic circulatory arrest (DHCA) exceeding 40 minutes, or total surgical time over 10 hours; (22) Any other conditions considered inappropriate for participation by the researchers.
Where it's running
-
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
- Email: pan_tuo@126.com
- Phone: +8615205160210
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Pregnancy-Related Aortic Dissection in China
This study looks at cases of aortic dissection that occur during pregnancy or shortly after, to understand outcomes for mothers and babies.
-
WeFlow-EndoPatch for Distal Aortic Tear Repair in Chronic Dissection
This study tests whether the WeFlow-EndoPatch Aortic Endovascular Patch can safely and effectively seal distal tears in chronic aortic dissection compared with standard treatment.
-
Aortic arch single-branch covered stent graft for treating aortic dissection
This trial tests a single-branch covered stent graft in adults with Stanford Type B aortic dissection who need revascularization of the left subclavian artery.
-
Multicenter study on acute type A aortic dissection
This study is trying to learn more about patients with acute type A aortic dissection by looking at their health details, surgeries, and recovery to see what affects their outcomes.
-
Shape‑memory polymer to seal the false lumen and prevent aortic enlargement
This trial will try a shape‑memory polymer implant to seal the false lumen and stop aortic growth in adults with type B dissection or treated type A dissection who need false lumen repair.
-
Using sivelestat to protect lung function after heart surgery
This study is testing if giving sivelestat to patients having emergency heart surgery can help protect their lungs and improve recovery by reducing serious complications.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.