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NCT Number: NCT06432387

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Larissa University Hospital, Larissa, Thessaly, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patients undergoing complex thoraco-abdominal aortic aneurysm repair

Other

Patients undergoing complex thoraco-abdominal aortic aneurysm repair

Primary outcomes

  1. Coagulation status

    Time frame: Day of surgery, 1st postoperative day, 4-5th postoperative day

    Early preoperatively, early and late postoperatively

  2. Myocardial injury after non cardiac surgery

    Time frame: Day of surgery, 1st postoperative day, 4-5th postoperative day

    Early preoperatively, early and late postoperatively

  3. Acute kidney injury

    Time frame: Day of surgery, 1st postoperative day, 4-5th postoperative day

    Early preoperatively, early and late postoperatively

  4. Post-implantation syndrome

    Time frame: Day of surgery, 1st postoperative day, 4-5th postoperative day

    Early preoperatively, early and late postoperatively

  5. Major cardiovascular events

    Time frame: Day of surgery, 1st postoperative day, 4-5th postoperative day

    Early preoperatively, early and late postoperatively

  6. Major cardiovascular events, implant failure and death of any cause

    Time frame: 30 days, 3, 6, and 12 months postoperatively

    Early preoperatively, early and late postoperatively and 1 at one month

Study contacts

Contact information is provided by the study sponsor or research team.

Eleni Arnaoutoglou, Prof

CONTACT

[email protected]

6974301352 ext. +30

Maria Ntalouka

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Registry information

Official study title

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

Acronym: CoFA-TAAA

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 29, 2024
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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