Thoraco-abdominal Aortic Aneurysm RepairCoFA-TAAANCT06432387
Coagulation Factors Alterations in Patients Undergoing Complex Thoraco-abdominal Aortic Aneurysm Repair
An observational study of Thoraco-abdominal Aortic Aneurysm Repair and Coagulation Factors Alterations, run by University of Thessaly at 2 sites in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoraco-abdominal Aortic Aneurysm Repair, Coagulation Factors Alterations, Platelet Activation
- What is being tested?
- Patients undergoing complex thoraco-abdominal aortic aneurysm repair
- How many people
- 58 participants
- Where
- 2 sitesGreece
- Study dates
- 31 Dec 2024to 20 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Consecutive patients undergoing complex thoraco-abdominal aortic aneurysm repair in University Hospital of Larissa, after informed consent will be included.
Who cannot join
- Refuse to participate
- Prior surgery within 3 months
- ASA PS > 3
- Known medical history of thrombophilia or functional platelet dysfunction
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Maria Ntalouka contact
Greece2 sites, 1 recruiting
- Recruiting
Larissa University Hospital
Larissa, Thessaly, 41110
Eleni Arnaoutoglou, Professor, 030241302952, earnaout@gmail.com
Maria P Ntalouka, Assistant Professor, +30 6973688099, maria.ntalouka@icloud.com
- Active, not recruiting
University of Thessaly
Larissa, 41335
About this study
Official title: 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.
Read the 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.
- Conditions
- Thoraco-abdominal Aortic Aneurysm Repair, Coagulation Factors Alterations, Platelet Activation
- Being tested
- Patients undergoing complex thoraco-abdominal aortic aneurysm repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients undergoing complex thoraco-abdominal aortic aneurysm repairOther
Patients undergoing complex thoraco-abdominal aortic aneurysm repair
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Patients undergoing complex thoraco-abdominal aortic aneurysm repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coagulation status
Early preoperatively, early and late postoperatively
Measured: Day of surgery, 1st postoperative day, 4-5th postoperative day
Myocardial injury after non cardiac surgery
Early preoperatively, early and late postoperatively
Measured: Day of surgery, 1st postoperative day, 4-5th postoperative day
Acute kidney injury
Early preoperatively, early and late postoperatively
Measured: Day of surgery, 1st postoperative day, 4-5th postoperative day
Post-implantation syndrome
Early preoperatively, early and late postoperatively
Measured: Day of surgery, 1st postoperative day, 4-5th postoperative day
Major cardiovascular events
Early preoperatively, early and late postoperatively
Measured: 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
Measured: 30 days, 3, 6, and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start31 Dec 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion20 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoraco-abdominal Aortic Aneurysm RepairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Arnaoutoglou, University of Thessaly
- Investigators
- Eleni Arnaoutoglou, Prof, Study chair, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432387
- Sponsor's protocol ID
- CoFA-TAAA
- Acronym
- CoFA-TAAA
- Status last verified
- May 2026
- First submitted
- 8 May 2024
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coagulation Factors Alterations in Patients Undergoing Complex Thoraco-abdominal Aortic Aneurysm Repair (CoFA-TAAA); a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06432387
- Acronym / sponsor ID
- CoFA-TAAA / CoFA-TAAA
- Conditions
- Thoraco-abdominal Aortic Aneurysm Repair, Coagulation Factors Alterations, Platelet Activation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 20 Jul 2027 (estimated)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing complex thoraco-abdominal aortic aneurysm repair | – | Other: Patients undergoing complex thoraco-abdominal aortic aneurysm repairPerioperative 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Consecutive patients undergoing complex thoraco-abdominal aortic aneurysm repair in University Hospital of Larissa, after informed consent will be included.
Key exclusion criteria (4 listed)
- Refuse to participate
- Prior surgery within 3 months
- ASA PS > 3
- Known medical history of thrombophilia or functional platelet dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients undergoing complex thoraco-abdominal aortic aneurysm repairPatients undergoing complex thoraco-abdominal aortic aneurysm repair | Other | Patients undergoing complex thoraco-abdominal aortic aneurysm repair |
Primary outcome
Coagulation status
Time frame: Day of surgery, 1st postoperative day, 4-5th postoperative day
Early preoperatively, early and late postoperatively
Myocardial injury after non cardiac surgery
Time frame: Day of surgery, 1st postoperative day, 4-5th postoperative day
Early preoperatively, early and late postoperatively
Acute kidney injury
Time frame: Day of surgery, 1st postoperative day, 4-5th postoperative day
Early preoperatively, early and late postoperatively
Post-implantation syndrome
Time frame: Day of surgery, 1st postoperative day, 4-5th postoperative day
Early preoperatively, early and late postoperatively
Major cardiovascular events
Time frame: Day of surgery, 1st postoperative day, 4-5th postoperative day
Early preoperatively, early and late postoperatively
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
Related trials for Thoraco-abdominal Aortic Aneurysm Repair
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Ntalouka contact
Eleni Arnaoutoglou, Prof study chair
University of Thessaly
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoraco-abdominal Aortic Aneurysm Repair and Coagulation Factors Alterations, run by University of Thessaly at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eleni Arnaoutoglou, Prof (6974301352 ext. +30, earnaout@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coagulation status (time frame: Day of surgery, 1st postoperative day, 4-5th postoperative day). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.