Aortic Dissection Clinical Trial
— AoArchOfficial title:
Early Complication and Outcomes in Surgical vs no Surgical Involvement of Aortic Arch in Type A Aortic Dissection
Verified date | January 2024 |
Source | Centre Cardiologique du Nord |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Acute Stanford type A aortic dissection (TAAD) is a life-threatening clinical status requiring surgery that is usually performed as a salvage procedure.We planned a multicenter study to evaluate the balance between the patient's condition and those therapeutic strategies that may limit the risk of late adverse events in patients who will be underwent surgery for appropriate management of TAAD
Status | Enrolling by invitation |
Enrollment | 800 |
Est. completion date | December 31, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Patients aged > 18 years - TAAD or intramural hematoma involving the ascending aorta - Symptoms started within 7 days from surgery - Primary surgical repair of acute TAAD - Any other major cardiac surgical procedure concomitant with surgery for TAAD. Exclusion Criteria: - Patients aged < 18 years - Onset of symptoms > 7 days from surgery - Prior procedure for TAAD - Concomitant endocarditis; - TAAD secondary to blunt or penetrating chest trauma. |
Country | Name | City | State |
---|---|---|---|
France | Francesco Nappi | Saint-Denis |
Lead Sponsor | Collaborator |
---|---|
Centre Cardiologique du Nord | Henri Mondor University Hospital, Hokkaido University, Pitié-Salpêtrière Hospital, Universita degli Studi di Genova |
France,
Benedetto U, Dimagli A, Kaura A, Sinha S, Mariscalco G, Krasopoulos G, Moorjani N, Field M, Uday T, Kendal S, Cooper G, Uppal R, Bilal H, Mascaro J, Goodwin A, Angelini G, Tsang G, Akowuah E. Determinants of outcomes following surgery for type A acute aor — View Citation
Czerny M, Schoenhoff F, Etz C, Englberger L, Khaladj N, Zierer A, Weigang E, Hoffmann I, Blettner M, Carrel TP. The Impact of Pre-Operative Malperfusion on Outcome in Acute Type A Aortic Dissection: Results From the GERAADA Registry. J Am Coll Cardiol. 20 — View Citation
Geirsson A, Shioda K, Olsson C, Ahlsson A, Gunn J, Hansson EC, Hjortdal V, Jeppsson A, Mennander A, Wickbom A, Zindovic I, Gudbjartsson T. Differential outcomes of open and clamp-on distal anastomosis techniques in acute type A aortic dissection. J Thorac — View Citation
Harris KM, Nienaber CA, Peterson MD, Woznicki EM, Braverman AC, Trimarchi S, Myrmel T, Pyeritz R, Hutchison S, Strauss C, Ehrlich MP, Gleason TG, Korach A, Montgomery DG, Isselbacher EM, Eagle KA. Early Mortality in Type A Acute Aortic Dissection: Insight — View Citation
O'Hara D, McLarty A, Sun E, Itagaki S, Tannous H, Chu D, Egorova N, Chikwe J. Type-A Aortic Dissection and Cerebral Perfusion: The Society of Thoracic Surgeons Database Analysis. Ann Thorac Surg. 2020 Nov;110(5):1461-1467. doi: 10.1016/j.athoracsur.2020.0 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Rate of urgent procedure | Number of participants who will require scheduled procedure within 24 hours of admission. | 30-days | |
Other | Rate of emergency grade 1 | Number of participants will require procedure within 24 hours of hospital admission and who are symptomatic or minimally symptomatic with stable hemodynamic conditions and no signs of malperfusion. | 30-days | |
Other | Rate of emergency grade 2 | Number of participants who will require procedure within the first 6 hours of hospital admission due to hemodynamic instability despite use of concentration inotropes and/or malperfusion. | 30-days | |
Other | Rate of salvage grade 1 | Number of participants who will require immediate surgical procedure. Rate of cardio pulmonary resuscitation with external chest compressions and/or open cardiac massage between induction of anesthesia and initiation of cardiopulmonary bypass. | 30-days | |
Other | Rate of salvage grade 2 | Number of participants who will require immediate surgical procedure. Rate of cardiopulmonary resuscitation with external chest compressions en route to the operating theatre or prior to induction of anesthesia. | 30-days | |
Primary | Operative Mortality (OM) | Patients who died within 30 days | 30-day | |
Primary | Rate of acute heart failure | Number of participants with postoperative heart failure who will require prolonged use of concentration of inotropes for a period greater than 24 h and/or the insertion of any mechanical circulatory support device. | 30-day | |
Primary | Stroke | Number of participants with acute episode of a focal or global neurological deficit. Rates of alteration of degree of consciousness, hemiplegia, hemiparesis, numbness or sensory loss affecting one side of the body, dysphasia or aphasia, hemianopsia, amaurosis fugax. To consider rate of other neurologic signs or symptoms consistent with stroke duration of focal or global neurologic deficit greater than 24 hours. | 30-day | |
Primary | Rate of global brain ischemia | Rate of diffuse hypoxic damage as diagnosed at brain imaging and electroencephalography. | 30-days | |
Primary | Rate of mesenteric ischemia | Rate of abdominal pain with or without nausea and vomiting and rectal bleeding or bloody diarrhea | 30-days | |
Primary | Rate of acute kidney injury | Number of participants with postoperative change in serum creatinine concentration. Severity will be stratified on the basis of number of participants with the KDIGO (Kney Disease Improving Global Outcomes) criteria. | 30-days | |
Secondary | Rate of paraplegia/paraparesis | Rate of bilateral weakness and/or multimodality sensory disturb- ance below the level of the ischemic spinal lesion. | 30-day | |
Secondary | Rate of perioperative bleeding | Number of participants will receive postoprative transfused red blood cell units. The E-CABG ( coronary artery by pass grafting) classification of bleeding rate has been proposed as a simple classification of perioperative bleeding | 30-day | |
Secondary | Rate of reoperation for bleeding | Number of participants who will receive postoperative chest reopening for excessive bleeding. | 30-day | |
Secondary | Rate of mechanical circulatory support | Number of participants who will receive the use of intra-aortic balloon pump and/or venoarterial extracorporeal membrane oxygenation for postoperative acute heart failure. | 30-day | |
Secondary | Late outcomes | Data on patient's survival status will be collected | 18 years |
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