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

Nanjing University

Status and phase: Enrolling; Phase 3

Conditions: Inflammation; Aortic Dissection

Treatments: Drug: Ketorolac; Drug: 0.9 % saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06968806

2025 -0039-02

Details and patient eligibility

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.

Full 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 be equally randomized to receive either ketorolac (intervention group: 60 mg intramuscular [IM] preoperatively followed by 30 mg twice daily [BID] for two days postoperatively) or matching placebo (control group), with both groups receiving standard perioperative care including analgesia, blood pressure control, and surgical treatment. Comprehensive data collection will include demographic characteristics, clinical parameters, laboratory tests (complete blood count [CBC], biochemistry, coagulation profile, cardiac enzymes, procalcitonin, cultures), and imaging studies (radiomics, biomechanics, chest X-ray, ultrasound, computed tomography [CT], magnetic resonance imaging [MRI]) at multiple timepoints from admission through 90-day follow-up. The primary outcomes will focus on evaluating the efficacy and safety of ketorolac through analysis of composite endpoint events, complication rates, and adverse reactions, with immediate study discontinuation and reporting for any treatment-related adverse events. All treatment protocols will maintain identical administration schedules and formulations between groups, with the exception of the active drug versus placebo.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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360 participants in 2 patient groups, including a placebo group

Ketorolac Group

Experimental group

Description:

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.

Treatment:

Drug: Ketorolac

Placebo Group

Placebo Comparator group

Description:

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

Treatment:

Drug: 0.9 % saline