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

NCT06968806 | Recruiting Phase 3 DMC

• 1 other identifier: 2025 -0039-02
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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 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

Aortic Dissection; Inflammation

Keywords

Inflammation; Aortic Dissection; Ketorolac

Outcome Measures

Primary Outcomes (1)

• Composite Endpoint: Mortality, Malperfusion Syndrome, Permanent Organ Dysfunction, Unplanned Cardiac Reoperation, and Prolonged Hospitalization

  The composite endpoint includes death (the worst outcome); malperfusion syndrome (including myocardial ischemia, stroke, lower limb paralysis, acute abdominal syndrome, renal failure requiring temporary dialysis, or symptoms and signs of limb ischemia); permanent dialysis, tracheostomy, or neurological deficits at discharge; postoperative mechanical circulatory support or unplanned cardiac reoperation (excluding reoperation for bleeding); postoperative cardiac arrest, multiple organ failure, or mechanical ventilation support for more than 72 hours; and postoperative hospital stay of 91 days or longer.

  Continuous intervention for 3 days after admission, with a 1-year follow-up.

Secondary Outcomes (26)

• erythrocyte sedimentation rate (ESR)

  Preoperative and postoperative assessments on days 1, 3, 5, 7, 30, and 90

• The perioperative use of opioids

  perioperative

• C-reactive protein (CRP)

  Preoperative and postoperative assessments on days 1, 3, 5, 7, 30, and 90

• interleukin-6 (IL-6)

  Preoperative and postoperative assessments on days 1, 3, 5, 7, 30, and 90

• Complete Blood Count (CBC)

  Preoperative and postoperative assessments on days 1, 3, 5, 7, 30, and 90

Study Arms (2)

Ketorolac Group

EXPERIMENTAL

patients in the experimental group will receive ketorolac treatment for Stanford Type A aortic dissection, consisting of a 60mg intramuscular injection preoperatively followed by 30mg twice daily for two days postoperatively, while maintaining standard baseline therapies including analgesia, blood pressure control, and subsequent cardiovascular surgical management.

Drug: Ketorolac

Placebo Group

PLACEBO COMPARATOR

The control group will receive identical placebo treatment (normal saline) with the same dosage regimen, formulation, and timing of administration as the experimental group, while also continuing all standard baseline treatments and surgical interventions without modification. Both groups will follow identical protocols except for the active drug versus placebo

Drug: 0.9 % saline

Interventions

Ketorolac DRUG

patients in the experimental group will receive ketorolac treatment for Stanford Type A aortic dissection, consisting of a 60mg intramuscular injection preoperatively followed by 30mg twice daily for two days postoperatively, while maintaining standard baseline therapies including analgesia, blood pressure control, and subsequent cardiovascular surgical management.

Ketorolac Group

0.9 % saline DRUG

0.9% saline

Placebo Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Stanford Type A aortic dissection confirmed by imaging and scheduled for emergency surgery.
• Aged between 18 and 65 years.
• Signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead
• Guangdong Provincial People's Hospital: collaborator
• Huai'an First People's Hospital: collaborator
• Shandong Provincial Hospital: collaborator
• First Affiliated Hospital of Harbin Medical University: collaborator
• The Second Affiliated Hospital of Harbin Medical University: collaborator
• THE FIRST AFFILIATED HOSPITAL OF SHIHEZI UNIVERSITY: collaborator
• Xinhua Hospital of Ili Kazak Autonomous Prefecture: collaborator
• Henan Provincial Chest Hospital: collaborator

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Aortic Dissection; Inflammation

Interventions

Ketorolac; Sodium Chloride

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Tuo Pan, MD

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  STUDY DIRECTOR

• DongJin Wang, MD

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  STUDY CHAIR

• DongJin Wang, MD

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuo Pan, MD

CONTACT

+8615205160210; pan_tuo@126.com

Dongjin Wang, MD

CONTACT

Dongjin_wang@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After enrollment, patients in the experimental group will receive ketorolac treatment for Stanford Type A aortic dissection, consisting of a 60mg intramuscular injection preoperatively followed by 30mg twice daily for two days postoperatively, while maintaining standard baseline therapies including analgesia, blood pressure control, and subsequent cardiovascular surgical management. The control group will receive identical placebo treatment (0.9% saline) with the same dosage regimen, formulation, and timing of administration as the experimental group, while also continuing all standard baseline treatments and surgical interventions without modification. Both groups will follow identical protocols except for the active drug versus placebo.

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: May 13, 2025
• Study Start: October 27, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: November 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)