Coagulopathy in Acute Aortic Syndrome

Recruiting

• Conditions: Coagulopathy

• Registration Number: NCT05149261
• Lead Sponsor: European Georges Pompidou Hospital

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.

Study Timeline

• Study Start: 2019-07-01
• Status Verified: 2021-11
• Study First Submitted: 2021-11-08
• Study First Submitted QC: 2021-11-25
• Last Update Submitted: 2021-11-25
• Study First Posted: 2021-12-08
• Last Update Posted: 2021-12-08
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
total transfusion requirements	Day 2	red blood cells units (number)
death from AAS	Day 30	probability of Survival (pourcentage %)
coagulopathy rTQ > 1.2 incidence	baseline	pourcentage %

Secondary Outcome Measures

Name	Time	Method
endotheliopathy	baseline	FGF basic ng/mL
total transfusion requirements	Day 7	red blood cell unit, fresh frozen plasma and platelets units
biological AAS coagulopathy : coagulation factors consumption	Day 7	pourcentage %
biological AAS coagulopathy : fibrinolysis D-dimers	Day 7	µg/L
symptoms-surgery delay	baseline	time hours
hospitalisation duration	hospital discharge	number of days
impact of misdiagnosis and misdiagnosis-induced treatments	Day 7	massive post-operative bleeding (BART definition)
clinical severity shock	baseline	number of organs with malperfusion (number)
platelets dysfunction	baseline	CD 40 L pg/mL

Trial Locations

Locations (1)

Université de Paris; 🇫🇷 Paris, France