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

Официальное название

Study on Ketorolac for Improving Outcomes and Prognosis in Patients With Stanford Type A Aortic Dissection -A Single-Center, Randomized, Double-Blind, Controlled Clinical Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Ketorolac
  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.
• Препарат 0.9 % saline
  0.9% saline

Первичные конечные точки

• Composite Endpoint: Mortality, Malperfusion Syndrome, Permanent Organ Dysfunction, Unplanned Cardiac Reoperation, and Prolonged Hospitalization [Срок оценки: Continuous intervention for 3 days after admission, with a 1-year follow-up.]

Вторичные конечные точки (12)

• erythrocyte sedimentation rate (ESR) [Срок оценки: Preoperative and postoperative assessments on days 1, 3, 5, 7, 30, and 90]
• The perioperative use of opioids [Срок оценки: perioperative]
• C-reactive protein (CRP) [Срок оценки: Preoperative and postoperative assessments on days 1, 3, 5, 7, 30, and 90]
• interleukin-6 (IL-6) [Срок оценки: Preoperative and postoperative assessments on days 1, 3, 5, 7, 30, and 90]
• Complete Blood Count (CBC) [Срок оценки: Preoperative and postoperative assessments on days 1, 3, 5, 7, 30, and 90]
• Procalcitonin (PCT) [Срок оценки: Preoperative and postoperative assessments on days 1, 3, 5, 7, 30, and 90]
• Prothrombin Time (PT) [Срок оценки: Preoperative and postoperative assessments on days 1, 3, 5, 7, 30, and 90]
• Activated Partial Thromboplastin Time (aPTT) [Срок оценки: Preoperative and postoperative assessments on days 1, 3, 5, 7, 30, and 90]
• Platelet function [Срок оценки: Preoperative and postoperative assessments on days 1, 3, 5, 7, 30, and 90]
• Alanine Aminotransferase (ALT) [Срок оценки: Preoperative and postoperative assessments on days 1, 3, 5, 7, 30, and 90]
• Creatinine [Срок оценки: Preoperative and postoperative assessments on days 1, 3, 5, 7, 30, and 90]
• Creatine Kinase (CK) [Срок оценки: Preoperative and postoperative assessments on days 1, 3, 5, 7, 30, and 90]

Критерии участия

Критерии включения

• Patients with Stanford Type A aortic dissection confirmed by imaging and scheduled for emergency surgery.

Aged between 18 and 65 years.

Signed informed consent.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Nanjing Drum Tower Hospital — Нанкин

Идентификаторы

NCT: NCT06968806 · 2025 -0039-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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