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

NCT ID: NCT06432387

Last Updated: 2024-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-31

Study Completion Date

2026-01-15

Brief Summary

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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

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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.

Conditions

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Thoraco-abdominal Aortic Aneurysm Repair Coagulation Factors Alterations Platelet Activation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Patients undergoing complex thoraco-abdominal aortic aneurysm repair

Intervention Type OTHER

Patients undergoing complex thoraco-abdominal aortic aneurysm repair

Interventions

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Patients undergoing complex thoraco-abdominal aortic aneurysm repair

Patients undergoing complex thoraco-abdominal aortic aneurysm repair

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Thessaly

OTHER

Sponsor Role lead

Responsible Party

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Elena Arnaoutoglou

Professor of Anaesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eleni Arnaoutoglou, Prof

Role: STUDY_CHAIR

University of Thessaly

Locations

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University of Thessaly

Larissa, , Greece

Site Status

Countries

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Greece

Central Contacts

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Eleni Arnaoutoglou, Prof

Role: CONTACT

6974301352 ext. +30

Maria Ntalouka

Role: CONTACT

Other Identifiers

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CoFA-TAAA

Identifier Type: -

Identifier Source: org_study_id

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