Aortic DissectionPhase 3NCT06968806
Study on Ketorolac for Improving Outcomes and Prognosis in Patients With Stanford Type A Aortic Dissection
A Phase 3 study testing Ketorolac and 0.9 % saline in people with Aortic Dissection and Inflammation, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Aortic Dissection, Inflammation
- What is being tested?
- Ketorolac and 0.9 % saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,346 participants
- Where
- 1 siteChina
- Study dates
- 27 Oct 2025to 1 Dec 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dongjin Wang, MD contact
China1 site, 1 recruiting
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Tuo Pan, MD, +8615205160210, pan_tuo@126.com
About this study
Official title: Efficacy and Safety of Ketorolac in Improving Prognosis of Stanford Type A Aortic Dissection: a Multicenter, Randomised, Double-blind, Controlled Clinical Trial
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.
Read the detailed description
This multicenter, randomized, double-blind, controlled clinical trial will enroll 1,346 eligible patients with Stanford Type A aortic dissection between October 2025 and December 2028. Participants will be equally randomized to receive either ketorolac (intervention group: 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 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.
- Conditions
- Aortic Dissection, Inflammation
- Being tested
- Ketorolac, 0.9 % saline
- Keywords
- Ketorolac, Stanford type A aortic dissection, RCT
- Medical subject headings
- Aortic Dissection, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
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.
0.9 % salineDrug
0.9% saline
| Study group | Role | What they receive |
|---|---|---|
| Ketorolac Group | Experimental | 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. Receives: 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 Receives: Drug: 0.9 % saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoints
In-hospital mortality and the occurrence of organ malperfusion syndrome (including myocardial ischemia, stroke, lower limb paralysis, acute abdominal pain, renal failure requiring temporary dialysis, or limb ischemia) during the hospitalization.
Measured: Continuous intervention for 3 days after admission, with a 1-year follow-up.
Secondary outcomes (26)
erythrocyte sedimentation rate (ESR)
erythrocyte sedimentation rate (ESR), an indicator of systemic inflammation that reflects the rate at which red blood cells settle in a vertical tube over a specified period. Elevated ESR levels may suggest ongoing inflammatory responses, infection, or tissue injury
Measured: Preoperative and postoperative assessments on days 1, 3, 5, 7, 30, and 90
The perioperative use of opioids
The perioperative use of opioids such as fentanyl and remifentanil is also assessed
Measured: perioperative
C-reactive protein (CRP)
C-reactive protein (CRP), an acute-phase protein synthesized by the liver that rises rapidly in response to infection, inflammation, or tissue injury. CRP serves as a sensitive biomarker of systemic inflammatory response and will be used to assess the perioperative inflammatory status in patients with Stanford Type A aortic dissection.
Measured: Preoperative and postoperative assessments on days 1, 3, 5, 7, 30, and 90
interleukin-6 (IL-6)
interleukin-6 (IL-6), a pro-inflammatory cytokine produced by various cells in response to tissue injury, infection, or stress. IL-6 plays a key role in the acute-phase inflammatory response and is closely associated with the severity of systemic inflammation.
Measured: Preoperative and postoperative assessments on days 1, 3, 5, 7, 30, and 90
Complete Blood Count (CBC)
A Complete Blood Count (CBC) is a common blood test that evaluates overall health and detects a wide range of disorders, including infections, anemia, and leukemia. It measures several components and features of the blood
Measured: Preoperative and postoperative assessments on days 1, 3, 5, 7, 30, and 90
Procalcitonin (PCT)
Procalcitonin (PCT) is a protein precursor of the hormone calcitonin, which is involved in calcium metabolism. Normally, PCT is produced in the thyroid C cells and is present in very low levels in the blood. However, during severe bacterial infections, levels rise significantly, making it a useful biomarker for diagnosing and monitoring bacterial infections, sepsis, and guiding antibiotic therapy.
Measured: Preoperative and postoperative assessments on days 1, 3, 5, 7, 30, and 90
Prothrombin Time (PT)
Prothrombin Time (PT) is a blood test that measures how long it takes for plasma to clot after adding thromboplastin (a reagent that activates the extrinsic pathway of coagulation). It evaluates the function of the extrinsic pathway (Factor VII) and common pathway (Factors X, V, II, and fibrinogen).
Measured: Preoperative and postoperative assessments on days 1, 3, 5, 7, 30, and 90
Activated Partial Thromboplastin Time (aPTT)
Activated Partial Thromboplastin Time (aPTT) is a fundamental coagulation test that measures the time required for plasma to clot after activation of the intrinsic pathway. This test evaluates the functionality of all coagulation factors except Factor VII and XIII.
Measured: Preoperative and postoperative assessments on days 1, 3, 5, 7, 30, and 90
Platelet function
Platelet function refers to the ability of platelets to participate in hemostasis through adhesion, activation, aggregation, and procoagulant activity. Proper platelet function is essential for primary hemostasis and vascular repair.
Measured: Preoperative and postoperative assessments on days 1, 3, 5, 7, 30, and 90
Alanine Aminotransferase (ALT)
Alanine Aminotransferase (ALT), also known as serum glutamate-pyruvate transaminase (SGPT), is a liver enzyme primarily found in hepatocytes. It plays a key role in amino acid metabolism by catalyzing the transfer of an amino group from alanine to α-ketoglutarate, producing pyruvate and glutamate.
Measured: Preoperative and postoperative assessments on days 1, 3, 5, 7, 30, and 90
Creatinine
Creatinine is a waste product generated from the breakdown of creatine phosphate in muscles. It is filtered by the kidneys and excreted in urine, making it a key marker for kidney function.
Measured: Preoperative and postoperative assessments on days 1, 3, 5, 7, 30, and 90
Creatine Kinase (CK)
Creatine Kinase (CK), also known as Creatine Phosphokinase (CPK), is an enzyme that plays a critical role in cellular energy metabolism. It catalyzes the conversion of creatine + ATP ↔ phosphocreatine + ADP, providing rapid energy for muscle contraction.
Measured: Preoperative and postoperative assessments on days 1, 3, 5, 7, 30, and 90
Cardiopulmonary Bypass (CPB) Time
Cardiopulmonary Bypass (CPB) Time refers to the duration (in minutes) during which a patient's circulatory and respiratory functions are temporarily supported by a heart-lung machine during cardiac surgery. This allows surgeons to operate on a still, bloodless heart.
Measured: Intraoperative
Total Surgical Duration
Total Surgical Duration refers to the entire time from skin incision to wound closure during a surgical procedure. It is a critical metric in perioperative medicine, influencing patient outcomes, resource utilization, and surgical team performance.
Measured: Intraoperative
Postoperative drainage
Postoperative drainage refers to the fluid collected from surgical sites via drains, providing critical information about healing and complications. Monitoring its volume and characteristics helps guide clinical decisions.
Measured: Perioperative/Periprocedural
Transfusion requirements
Transfusion requirements refer to the amount and type of blood products needed during or after surgery to maintain adequate oxygenation, hemostasis, and hemodynamic stability. The volume transfused depends on blood loss, preoperative anemia, and patient physiology.
Measured: Perioperative/Periprocedural
Postoperative sternal infection (PSI)
Postoperative sternal infection (PSI) refers to surgical site infections involving the sternum after cardiac or thoracic surgery, particularly following median sternotomy. These infections range from superficial wound complications to life-threatening mediastinitis.
Measured: Perioperative/Periprocedural
Number of Participants with breakthrough pain
Incidence: 20-40% of surgical patients experience inadequately controlled pain requiring rescue analgesia.
Risk Factors:
Major surgery (e.g., orthopedic, abdominal)
Preoperative opioid use
Younger age
Measured: Perioperative/Periprocedural
Number of Participants with nausea
Nausea is an unpleasant, subjective sensation of impending vomiting, often accompanied by autonomic symptoms like pallor, sweating, and increased salivation. As a common postoperative complication, it represents a significant challenge in perioperative care.
Measured: Perioperative/Periprocedural
Number of Participants with vomiting
Vomiting (emesis) is the forceful expulsion of gastric contents through the mouth resulting from coordinated contractions of the abdominal, thoracic, and gastrointestinal musculature. As a protective reflex mediated by the brainstem, it serves to eliminate harmful substances but becomes clinically significant when occurring postoperatively or pathologically.
Measured: Perioperative/Periprocedural
Number of Participants with gastrointestinal discomfort
Gastrointestinal (GI) discomfort refers to a spectrum of subjective abdominal symptoms occurring postoperatively, distinct from nausea/vomiting. This nonspecific symptom complex affects 15-40% of surgical patients and significantly impacts recovery trajectories.
Measured: Perioperative/Periprocedural
aortic tissue density
imaging-based radiomics and biomechanical analyses from CTA and other modalities are used to evaluate aortic tissue density
Measured: the 1-year follow-up
aortic tissue strength
maging-based radiomics and biomechanical analyses from CTA and other modalities are used to evaluate aortic tissue strength
Measured: the 1-year follow-up
abnormal blood flow
imaging-based radiomics and biomechanical analyses from CTA and other modalities are used to evaluate abnormal blood flow
Measured: the 1-year follow-up
Survival rate
Survival rate refers to the percentage of patients who remain alive for a specified period after diagnosis or treatment of a disease. It is a key metric in evaluating treatment efficacy, disease prognosis, and healthcare outcomes.
Measured: the 1-year follow-up
Postoperative recovery and complications
ICU length of stay, duration of mechanical ventilation, total hospital stay, incidence of pneumonia, permanent dialysis, tracheostomy, neurological dysfunction, secondary debridement, cardiac arrest, mechanical circulatory support, or unplanned cardiac reoperation (excluding those due to bleeding), postoperative cardiac arrest, multiple organ dysfunction, and mechanical ventilation duration exceeding 72 hours.
Measured: he 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start27 Oct 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After enrollment, 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. 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,346 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Provincial People's Hospital, Huai'an First People's Hospital, Shandong Provincial Hospital, First Affiliated Hospital of Harbin Medical University, The Second Affiliated Hospital of Harbin Medical University, The First Affiliated Hospital of Shihezi University, Xinhua Hospital of Ili Kazak Autonomous Prefecture, Henan Provincial Chest Hospital, First Affiliated Hospital of Zhejiang University
- Responsible party
- Sponsor
- Investigators
- Tuo Pan, MD, Study director, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolDongJin Wang, MD, Study chair, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolDongJin Wang, MD, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968806
- Sponsor's protocol ID
- 2025 -0039-02
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No