Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06968806

PHASE3

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

Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

View on ClinicalTrials.gov

Summary

This multicenter, randomized, double-blind, placebo-controlled trial evaluates the efficacy and safety of ketorolac in 1,346 patients with Stanford Type A aortic dissection, conducted between 2025 and 2028. Participants will receive either ketorolac (60 mg intramuscularly \[IM\] within 6 hours before surgery and 30 mg im twice daily（at 6:00 AM and 6:00 PM, respectively 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.

Official title: Efficacy and Safety of Ketorolac in Improving Prognosis of Stanford Type A Aortic Dissection: a Multicenter, Randomised, Double-blind, Controlled Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

1346

Start Date

2025-10-27

Completion Date

2028-12-01

Last Updated

2026-08-31

Healthy Volunteers

Conditions

Aortic Dissection Inflammation

Interventions

DRUG

Ketorolac

patients in the experimental group will receive ketorolac treatment for Stanford Type A aortic dissection, consisting of a 60mg intramuscular injection within 6 hours before surgery followed by 30mg im twice daily(at 6:00 AM and 6:00 PM, respectively )for two days postoperatively, while maintaining standard baseline therapies including analgesia, blood pressure control, and subsequent cardiovascular surgical management.

DRUG

0.9 % saline

0.9% saline

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.

Locations (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China