Clinical trial NCT06432387: Coagulation Factors Alterations in Patients Undergoing Complex Thoraco-abdominal Aortic Aneurysm Repair
Official title: Coagulation Factors Alterations in Patients Undergoing Complex Thoraco-abdominal Aortic Aneurysm Repair (CoFA-TAAA); a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Thoraco-abdominal Aortic Aneurysm Repair
Coagulation Factors Alterations
Platelet Activation
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients undergoing complex thoraco-abdominal aortic aneurysm repair in University Hospital of Larissa, after informed consent will be included.

Exclusion Criteria:

* Refuse to participate
* Prior surgery within 3 months
* ASA PS \> 3
* Known medical history of thrombophilia or functional platelet dysfunction

Primary outcomes:
measure: Coagulation status
timeFrame: Day of surgery, 1st postoperative day, 4-5th postoperative day
measure: Myocardial injury after non cardiac surgery
timeFrame: Day of surgery, 1st postoperative day, 4-5th postoperative day
measure: Acute kidney injury
timeFrame: Day of surgery, 1st postoperative day, 4-5th postoperative day
measure: Post-implantation syndrome
timeFrame: Day of surgery, 1st postoperative day, 4-5th postoperative day
measure: Major cardiovascular events
timeFrame: Day of surgery, 1st postoperative day, 4-5th postoperative day
measure: Major cardiovascular events, implant failure and death of any cause
timeFrame: 30 days, 3, 6, and 12 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: University of Thessaly
Study officials:
affiliation: University of Thessaly
name: Eleni Arnaoutoglou, Prof
role: STUDY_CHAIR
References: