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Coagulopathy in Acute Aortic Syndrome

NCT ID: NCT05149261

Last Updated: 2021-12-08

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

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2024-12-31

Brief Summary

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The existence of AAS coagulopathy has been reported, related to blood contact with the walls of the non-endothelialized false lumens. It is likely that endothelial dysfunction generated by vascular lesions may largely contribute to the development of coagulopathy, such as described in trauma-induced coagulopathy. This endotheliopathy of the AAS has never been evaluated. The coagulopathy of AAS and more specifically the endotheliopathy are poorly described and therefore have no standardized treatment.

The main objective of this study is to describe the coagulopathy

Detailed Description

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Acute aortic syndromes (AAS) result from an organic lesion of the aortic wall. The various symptoms of AAS, mainly the acute chest pain, leads to a breakdown of the intima or the media of the aorta. This syndrome is made of three entities : aortic dissection (DA), intra-mural hematoma (HIM) and penetrating atherosclerotic ulcer (PAU). Surgery is a complex emergency treatment of choice. Patients suffering from these pathologies die mainly from hemorrhagic shock due to haemostasis disorders, which requires massive transfusion. The existence of AAS coagulopathy has been reported, related to blood contact with the walls of the non-endothelialized false lumens. It is likely that endothelial dysfunction generated by vascular lesions may largely contribute to the development of coagulopathy, such as described in trauma-induced coagulopathy. This endotheliopathy of the AAS has never been evaluated. The coagulopathy of AAS and more specifically the endotheliopathy are poorly described and therefore have no standardized treatment.

The main objective of this study is to describe the coagulopathy and more specifically the endotheliopathy of AAS, in particular assessing coagulation disorders, hyperactivation of fibrinolysis, quantitative or functional platelets disorder and endotheliopathy. The secondary objective is to determine the factors associated with this coagulopathy. This includes 1 / assessment of potential risk factors for coagulopathy, 2 / the prognosis of coagulopathy by assessing the relationship between coagulopathy and transfusion requirements and mortality.

Conditions

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Coagulopathy

Keywords

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Coagulopathy Acute aortic dissection Blood transfusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute aortic syndrome

patients admitted to the Georges Pompidou European Hospital via the "SOS aorta" network

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* admitted to hospital via the "SOS Aorta" network for acute aortic syndrome (AAS) suspicion

Exclusion Criteria

* aged \< 18y
* pregnant women
* no social security
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Georges Pompidou Hospital

OTHER

Sponsor Role lead

Responsible Party

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Diane Zlotnik

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Diane Zlotnik, MD

Role: PRINCIPAL_INVESTIGATOR

European Georges Pompidou Hospital

Anne Godier, MD-PhD

Role: STUDY_CHAIR

European Georges Pompidou Hospital

Locations

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Université de Paris

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Diane Zlotnik, MD

Role: CONTACT

Phone: +33156092428

Email: [email protected]

Anne Godier, MD-PhD

Role: CONTACT

Phone: +33156092584

Email: [email protected]

Facility Contacts

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Anne Godier, MD-PhD

Role: primary

Other Identifiers

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SAACOAG

Identifier Type: -

Identifier Source: org_study_id