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

Platelet Activation Clinical Trial

— CoFA-TAAA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06432387
• Other study ID #: CoFA-TAAA
• Status: Not yet recruiting
• Start date: May 31, 2024
• Est. completion date: January 15, 2026

Study information

• Verified date: May 2024
• Source: University of Thessaly
• Contact: Eleni Arnaoutoglou, Prof
• Phone: 6974301352
• Email: earnaout[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: January 15, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Aortic Aneurysm, Thoracic
• Aortic Aneurysm, Thoracoabdominal
• Platelet Activation

Intervention

Other:
• Patients undergoing complex thoraco-abdominal aortic aneurysm repair
Patients undergoing complex thoraco-abdominal aortic aneurysm repair

Locations

Country	Name	City	State
Greece	University of Thessaly	Larissa

Sponsors (1)

Lead Sponsor	Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coagulation status	Early preoperatively, early and late postoperatively	Day of surgery, 1st postoperative day, 4-5th postoperative day
Primary	Myocardial injury after non cardiac surgery	Early preoperatively, early and late postoperatively	Day of surgery, 1st postoperative day, 4-5th postoperative day
Primary	Acute kidney injury	Early preoperatively, early and late postoperatively	Day of surgery, 1st postoperative day, 4-5th postoperative day
Primary	Post-implantation syndrome	Early preoperatively, early and late postoperatively	Day of surgery, 1st postoperative day, 4-5th postoperative day
Primary	Major cardiovascular events	Early preoperatively, early and late postoperatively	Day of surgery, 1st postoperative day, 4-5th postoperative day
Primary	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