Coagulopathy in Acute Aortic Syndrome

Study Overview
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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.

Official Title
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Coagulopathy in Acute Aortic Syndrome

Conditions
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Coagulopathy

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute aortic syndrome<br>patients admitted to the Georges Pompidou European Hospital via the SOS aorta network | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total transfusion requirements | red blood cell unit, fresh frozen plasma and platelets units (number) | Day 1 | 
| total transfusion requirements | red blood cell unit, fresh frozen plasma and platelets units (number) | Day 2 | 
| total transfusion requirements | red blood cell unit, fresh frozen plasma and platelets units | Day 3 | 
| total transfusion requirements | red blood cell unit, fresh frozen plasma and platelets units | Day 7 | 
| biological AAS coagulopathy : coagulation factors consumption | pourcentage % | Day 1, Day 2, Day 3, Day 7 | 
| biological AAS coagulopathy : coagulation factors consumption | pourcentage % | Day 2 | 
| biological AAS coagulopathy : coagulation factors consumption | pourcentage % | Day 3 | 
| biological AAS coagulopathy : coagulation factors consumption | pourcentage % | Day 7 | 
| biological AAS coagulopathy : fibrinolysis D-dimers | µg/L | Day 1 | 
| biological AAS coagulopathy : fibrinolysis D-dimers | µg/L | Day 2 | 
| biological AAS coagulopathy : fibrinolysis D-dimers | µg/L | Day 3 | 
| biological AAS coagulopathy : fibrinolysis D-dimers | µg/L | Day 7 | 
| hospitalisation duration | number of days | hospital discharge | 
| impact of misdiagnosis and misdiagnosis-induced treatments | massive post-operative bleeding (BART definition) | Day 2 | 
| impact of misdiagnosis and misdiagnosis-induced treatments | massive post-operative bleeding (BART definition) | Day 7 | 
| platelets dysfunction | platelets rate G/L | day 1 | 
| platelets dysfunction | platelets rate G/L | day 2 | 
| platelets dysfunction | platelets rate G/L | day 3 | 
| platelets dysfunction | platelets rate G/L | day 7 | 
| platelets dysfunction | CD 40 L pg/mL | baseline | 
| endotheliopathy | IL6 rate pg/mL | baseline | 
| endotheliopathy | IL8 rate pg/mL | baseline | 
| endotheliopathy | syndecan rate pg/mL | baseline | 
| endotheliopathy | endocan rate pg/mL | baseline | 
| endotheliopathy | angiopoietine 2 rate ng/mL | baseline | 
| endotheliopathy | angiopoietine 2 / angiopoietine 2 ratio | baseline | 
| endotheliopathy | VEGF ng/mL | baseline | 
| endotheliopathy | FGF basic ng/mL | baseline | 
| symptoms-surgery delay | time hours | baseline | 
| clinical severity shock | acidosis pH | baseline | 
| clinical severity shock | lactate level (mmol/L) | baseline | 
| clinical severity shock | number of organs with malperfusion (number) | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coagulopathy, Acute aortic dissection, Blood transfusion