Coagulation Factors Alterations in Patients Undergoing Complex Thoraco-abdominal Aortic Aneurysm Repair

NCT06432387 | Not Yet Recruiting

• 1 other identifier: CoFA-TAAA
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoraco-abdominal Aortic Aneurysm Repair; Coagulation Factors Alterations; Platelet Activation

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

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.

Other: Patients undergoing complex thoraco-abdominal aortic aneurysm repair

Interventions

Patients undergoing complex thoraco-abdominal aortic aneurysm repair OTHER

Patients undergoing complex thoraco-abdominal aortic aneurysm repair

Patients undergoing complex thoraco-abdominal aortic aneurysm repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

University of Thessaly

Larissa, 41335, Greece

Location

Study Officials

• Eleni Arnaoutoglou, Prof

  University of Thessaly

  STUDY CHAIR

Central Study Contacts

Eleni Arnaoutoglou, Prof

CONTACT

6974301352; earnaout@gmail.com

Maria Ntalouka

CONTACT

maria.ntalouka@icloud.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anaesthesiology

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 29, 2024
• Study Start: May 31, 2024
• Primary Completion: December 31, 2025
• Study Completion: January 15, 2026
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)