## Protocol Section
### Identification Module
**NCT ID:** NCT06432387

**Acronym:** CoFA-TAAA

**Brief Title:** Coagulation Factors Alterations in Patients Undergoing Complex Thoraco-abdominal Aortic Aneurysm Repair

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

#### Organization Study ID Info
**ID:** CoFA-TAAA
#### Organization
**Class:** OTHER
**Full Name:** University of Thessaly
### Status Module
#### Completion Date
**Date:** 2026-01-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-28

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Thessaly

#### Responsible Party

**Investigator Affiliation:** University of Thessaly

**Investigator Full Name:** Elena Arnaoutoglou

**Investigator Title:** Professor of Anaesthesiology

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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.

**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 Module

**Conditions:**

- Thoraco-abdominal Aortic Aneurysm Repair

- Coagulation Factors Alterations

- Platelet Activation

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 58

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

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

**Label:** Patients undergoing complex thoraco-abdominal aortic aneurysm repair

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Patients undergoing complex thoraco-abdominal aortic aneurysm repair

**Description:** Patients undergoing complex thoraco-abdominal aortic aneurysm repair

**Name:** Patients undergoing complex thoraco-abdominal aortic aneurysm repair

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Early preoperatively, early and late postoperatively

**Measure:** Coagulation status

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

**Measure:** Myocardial injury after non cardiac surgery

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

**Measure:** Acute kidney injury

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

**Measure:** Post-implantation syndrome

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

**Measure:** Major cardiovascular events

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

**Measure:** Major cardiovascular events, implant failure and death of any cause

**Time Frame:** 30 days, 3, 6, and 12 months postoperatively

### Eligibility Module

**Eligibility Criteria:** 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 Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** earnaout@gmail.com

**Name:** Eleni Arnaoutoglou, Prof

**Phone:** 6974301352

**Phone Ext:** +30

**Role:** CONTACT

**Contact 2:**

**Email:** maria.ntalouka@icloud.com

**Name:** Maria Ntalouka

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Larissa

**Country:** Greece

**Facility:** University of Thessaly

**Zip:** 41335

#### Overall Officials

**Official 1:**

**Affiliation:** University of Thessaly

**Name:** Eleni Arnaoutoglou, Prof

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000001018

- Term: Aortic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M4113

- Name: Aneurysm

- Relevance: HIGH

- As Found: Aneurysm

- ID: M4330

- Name: Aortic Aneurysm

- Relevance: HIGH

- As Found: Aortic Aneurysm

- ID: M19800

- Name: Aortic Aneurysm, Abdominal

- Relevance: HIGH

- As Found: Abdominal Aortic Aneurysm

- ID: M3070

- Name: Aortic Aneurysm, Thoracoabdominal

- Relevance: HIGH

- As Found: Thoraco-Abdominal Aortic Aneurysm

- ID: M19801

- Name: Aortic Aneurysm, Thoracic

- Relevance: HIGH

- As Found: Thoraco-Abdominal Aortic Aneurysm

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4334

- Name: Aortic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T66

- Name: Abdominal Aortic Aneurysm

- Relevance: HIGH

- As Found: Abdominal Aortic Aneurysm

### Condition Browse Module - Meshes

- ID: D000000783

- Term: Aneurysm

- ID: D000001014

- Term: Aortic Aneurysm

- ID: D000017544

- Term: Aortic Aneurysm, Abdominal

- ID: D000094624

- Term: Aortic Aneurysm, Thoracoabdominal

- ID: D000017545

- Term: Aortic Aneurysm, Thoracic

### Intervention Browse Module - Browse Branches

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: FiAg

- Name: Fibrinolytic Agents

- Abbrev: AnCoag

- Name: Anticoagulants

- Abbrev: Coag

- Name: Coagulants

### Intervention Browse Module - Browse Leaves

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

- ID: M9581

- Name: Heparin, Low-Molecular-Weight

- Relevance: LOW

- As Found: Unknown

- ID: M20153

- Name: Dalteparin

- Relevance: LOW

- As Found: Unknown

- ID: M203832

- Name: Fibrin fragment D

- Relevance: LOW

- As Found: Unknown

- ID: M8312

- Name: Factor VIII

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
