Coagulation Factors Alterations in Patients Undergoing Complex Thoraco-abdominal Aortic Aneurysm Repair
- Conditions
- Platelet ActivationThoraco-abdominal Aortic Aneurysm RepairCoagulation Factors Alterations
- Interventions
- Other: Patients undergoing complex thoraco-abdominal aortic aneurysm repair
- Registration Number
- NCT06432387
- Lead Sponsor
- University of Thessaly
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 58
- Consecutive patients undergoing complex thoraco-abdominal aortic aneurysm repair in University Hospital of Larissa, after informed consent will be included.
- Refuse to participate
- Prior surgery within 3 months
- ASA PS > 3
- Known medical history of thrombophilia or functional platelet dysfunction
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients undergoing complex thoraco-abdominal aortic aneurysm repair 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.
- Primary Outcome Measures
Name Time Method Coagulation status Day of surgery, 1st postoperative day, 4-5th postoperative day Early preoperatively, early and late postoperatively
Myocardial injury after non cardiac surgery Day of surgery, 1st postoperative day, 4-5th postoperative day Early preoperatively, early and late postoperatively
Acute kidney injury Day of surgery, 1st postoperative day, 4-5th postoperative day Early preoperatively, early and late postoperatively
Post-implantation syndrome Day of surgery, 1st postoperative day, 4-5th postoperative day Early preoperatively, early and late postoperatively
Major cardiovascular events Day of surgery, 1st postoperative day, 4-5th postoperative day Early preoperatively, early and late postoperatively
Major cardiovascular events, implant failure and death of any cause 30 days, 3, 6, and 12 months postoperatively Early preoperatively, early and late postoperatively and 1 at one month
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Thessaly
🇬🇷Larissa, Greece