Coagulation Factors Alterations in Patients Undergoing Complex Thoraco-abdominal Aortic Aneurysm Repair (CoFA-TAAA)

Coagulation Factors Alterations in Patients Undergoing Complex Thoraco-abdominal Aortic Aneurysm Repair (CoFA-TAAA); a Prospective Observational Study

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.

Study Overview

• Status: Recruiting
• Conditions: Platelet Activation; Thoraco-abdominal Aortic Aneurysm Repair; Coagulation Factors Alterations
• Intervention / Treatment: Other: Patients undergoing complex 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.

• Study Type: Observational
• Enrollment (Estimated): 58

Contacts and Locations

• Study Contact: Name: Eleni Arnaoutoglou, Prof; Phone Number: +30 6974301352; Email: earnaout@gmail.com
• Study Contact Backup: Name: Maria Ntalouka; Email: maria.ntalouka@icloud.com

Study Locations

• Greece
  • Larissa, Greece, 41335
    • Active, not recruiting
    • University of Thessaly
  • Thessaly
    • Larissa, Thessaly, Greece, 41110
      • Recruiting
      • Larissa University Hospital
      • Contact: Eleni Arnaoutoglou, Professor; Phone Number: 030241302952; Email: earnaout@gmail.com
      • Contact: Maria P Ntalouka, Assistant Professor; Phone Number: +30 6973688099; Email: maria.ntalouka@icloud.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; Patients undergoing complex thoraco-abdominal aortic aneurysm repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Thessaly
• Investigators: Study Chair: Eleni Arnaoutoglou, Prof, University of Thessaly

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 20, 2027

Study Registration Dates

• First Submitted: May 8, 2024
• First Submitted That Met QC Criteria: May 28, 2024
• First Posted (Actual): May 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 3, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracic; Aortic Aneurysm, Thoracoabdominal
• Other Study ID Numbers: CoFA-TAAA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No