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Coagulopathy in Acute Aortic Syndrome

Coagulopathy in Acute Aortic Syndrome

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05149261
Acronym
SAACAOG
Enrollment
500
Registered
2021-12-08
Start date
2019-07-01
Completion date
2024-12-31
Last updated
2021-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coagulopathy

Keywords

Coagulopathy, Acute aortic dissection, Blood transfusion

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

Detailed description

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.

Interventions

None listed

Sponsors

European Georges Pompidou Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
total transfusion requirementsDay 2red blood cells units (number)
death from AASDay 30probability of Survival (pourcentage %)
coagulopathy rTQ > 1.2 incidencebaselinepourcentage %

Secondary

MeasureTime frameDescription
total transfusion requirementsDay 1red blood cell unit, fresh frozen plasma and platelets units (number)
biological AAS coagulopathy : coagulation factors consumptionDay 1, Day 2, Day 3, Day 7pourcentage %
biological AAS coagulopathy : fibrinolysis D-dimersDay 1µg/L
hospitalisation durationhospital dischargenumber of days
impact of misdiagnosis and misdiagnosis-induced treatmentsDay 2massive post-operative bleeding (BART definition)
platelets dysfunctionday 1platelets rate G/L
endotheliopathybaselineIL6 rate pg/mL
symptoms-surgery delaybaselinetime hours
clinical severity shockbaselineacidosis pH

Countries

France

Contacts

Primary ContactDiane Zlotnik, MD
diane.zlotnik@aphp.fr+33156092428
Backup ContactAnne Godier, MD-PhD
anne.godier@aphp.fr+33156092584

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026