Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the impact of complex thoraco-abdominal aortic aneurysm repair in coagulation during the immediate postoperative period in patients undergoing omplex thoraco-abdominal aortic aneurysm repair.
Endovascular aneurysm repair of abdominal aorta activates a significant inflammation reaction and has an impact on coagulation. Platelet activation seems to have a major role in this prothrombotic and hypercoagulable state. In complex thoraco-abdominal aortic aneurysm repair the implants are more complexed and the duration of operation longer. The main hypothesis is that all the above have a greater impact on platelet activation and coagulation alterations.
The aim of this study is the evaluation of the impact of complex thoraco-abdominal aortic aneurysm repair in coagulation during the immediate postoperative period in patients undergoing omplex thoraco-abdominal aortic aneurysm repair.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing complex thoraco-abdominal aortic aneurysm repair | Perioperative laboratory examinations will follow institutional guidelines. These will include, but will not be limited to full blood count, conventional coagulation tests, liver function, and kidney function tests. Moreover, for the purpose of this study, the following parameters will also be obtained; vWF, factors VIII and XI, D-dimers, fibrinogen, platelets activation (multiplate), adams-13, anti-Xa and high sensitivity troponin. All samples will be obtained via puncture from a peripheral vein. Blood samples will obtained at three time points; preoperatively before induction to GA (01), postoperative day 1 (02) and postoperative day 3rd-4th (03). During hospitalization any myocardial injury after non cardiac surgery, acute kidney injure and post-implantation syndrome will be recorded. Of note, at 30 days, 3, 6 and 12 months our patients will undergo an evaluation for any major cardiovascular event, implant failure or death of any cause. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients undergoing complex thoraco-abdominal aortic aneurysm repair | Other | Patients undergoing complex thoraco-abdominal aortic aneurysm repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| Coagulation status | Early preoperatively, early and late postoperatively | Day of surgery, 1st postoperative day, 4-5th postoperative day |
| Myocardial injury after non cardiac surgery | Early preoperatively, early and late postoperatively | Day of surgery, 1st postoperative day, 4-5th postoperative day |
| Acute kidney injury | Early preoperatively, early and late postoperatively | Day of surgery, 1st postoperative day, 4-5th postoperative day |
| Post-implantation syndrome | Early preoperatively, early and late postoperatively | Day of surgery, 1st postoperative day, 4-5th postoperative day |
| Major cardiovascular events | Early preoperatively, early and late postoperatively | Day of surgery, 1st postoperative day, 4-5th postoperative day |
| Major cardiovascular events, implant failure and death of any cause | Early preoperatively, early and late postoperatively and 1 at one month | 30 days, 3, 6, and 12 months postoperatively |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
All patients will be treated by the same medical team in UHL according to the European Society for Vascular Surgery (ESVS) guidelines. Preoperatively patients will be treated with aspirin 100 mg once daily for at least 5 days. Postoperatively in the absence of bleeding patients will receive aspirin 100 mg and in the absence of neurological dysfunction due to spine ischemia they will receive clopidogrel 150 mg and from the next day dual antiplatelet therapy (aspirin 100 mg and clopidogrel 75 mg). If the patient was treated with anticoagulant agents this will be discontinued preoperative according to ACCP guidelines and it will be restarted on the 1st or 2nd postoperative day based on hemostasis. In this case patients will be treated with aspirin 100 mg once daily five days preoperatively and aspirin will also be continued postoperatively.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eleni Arnaoutoglou, Prof | Contact | 6974301352 | +30 | earnaout@gmail.com |
| Maria Ntalouka | Contact | maria.ntalouka@icloud.com |
| Name | Affiliation | Role |
|---|---|---|
| Eleni Arnaoutoglou, Prof | University of Thessaly | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Larissa University Hospital | Recruiting | Larissa | Thessaly | 41110 | Greece |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| University of Thessaly | Active, not recruiting | Larissa | 41335 | Greece |