Coagulopathy in Acute Aortic Syndrome

NCT05149261 | Unknown DMC

• 1 other identifier: SAACOAG
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coagulopathy

Keywords

Coagulopathy; Acute aortic dissection; Blood transfusion

Outcome Measures

Primary Outcomes (3)

• total transfusion requirements

  red blood cells units (number)

  Day 2

• death from AAS

  probability of Survival (pourcentage %)

  Day 30

• coagulopathy rTQ > 1.2 incidence

  pourcentage %

  baseline

Secondary Outcomes (32)

• total transfusion requirements

  Day 1

• total transfusion requirements

  Day 2

• total transfusion requirements

  Day 3

• total transfusion requirements

  Day 7

• biological AAS coagulopathy : coagulation factors consumption

  Day 1, Day 2, Day 3, Day 7

Study Arms (1)

Acute aortic syndrome

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The EGPH offers, since 2009, a multidisciplinary network called "SOS Aorta" to centralize clinico-radiological suspicions of acute aortic syndrome in Ile de France and provide responsive and accessible medico-surgical care permanently. We included prospectively and analysed retrospectively (descripive study) all patient aged more than 18y who were admitted at EGPH for AAS suspicion via SOS Aorta Network.

You may qualify if:

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

You may not qualify if:

• aged \< 18y
• pregnant women
• no social security

Sponsors & Collaborators

• European Georges Pompidou Hospital: lead

Study Sites (1)

Université de Paris

Paris, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Routine care blood samples will be taken at different moments of the hospital stay

MeSH Terms

Conditions

Hemostatic Disorders

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Diane Zlotnik, MD

  European Georges Pompidou Hospital

  PRINCIPAL INVESTIGATOR

• Anne Godier, MD-PhD

  European Georges Pompidou Hospital

  STUDY CHAIR

Central Study Contacts

Diane Zlotnik, MD

CONTACT

+33156092428; diane.zlotnik@aphp.fr

Anne Godier, MD-PhD

CONTACT

+33156092584; anne.godier@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: December 8, 2021
• Study Start: July 1, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 8, 2021

Record last verified: 2021-11

Locations

FR (1)