Coagulopathy in Acute Aortic Syndrome

Coagulopathy Clinical Trial

— SAACAOG  

Official title:

Coagulopathy in Acute Aortic Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05149261
• Other study ID #: SAACOAG
• Status: Recruiting
• Start date: July 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2021
• Source: European Georges Pompidou Hospital
• Contact: Diane Zlotnik, MD
• Phone: +33156092428
• Email: diane.zlotnik[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulopathy
• Hemostatic Disorders

Locations

Country	Name	City	State
France	Université de Paris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
European Georges Pompidou Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total transfusion requirements	red blood cells units (number)	Day 2
Primary	death from AAS	probability of Survival (pourcentage %)	Day 30
Primary	coagulopathy rTQ > 1.2 incidence	pourcentage %	baseline
Secondary	total transfusion requirements	red blood cell unit, fresh frozen plasma and platelets units (number)	Day 1
Secondary	total transfusion requirements	red blood cell unit, fresh frozen plasma and platelets units (number)	Day 2
Secondary	total transfusion requirements	red blood cell unit, fresh frozen plasma and platelets units	Day 3
Secondary	total transfusion requirements	red blood cell unit, fresh frozen plasma and platelets units	Day 7
Secondary	biological AAS coagulopathy : coagulation factors consumption	pourcentage %	Day 1, Day 2, Day 3, Day 7
Secondary	biological AAS coagulopathy : coagulation factors consumption	pourcentage %	Day 2
Secondary	biological AAS coagulopathy : coagulation factors consumption	pourcentage %	Day 3
Secondary	biological AAS coagulopathy : coagulation factors consumption	pourcentage %	Day 7
Secondary	biological AAS coagulopathy : fibrinolysis D-dimers	µg/L	Day 1
Secondary	biological AAS coagulopathy : fibrinolysis D-dimers	µg/L	Day 2
Secondary	biological AAS coagulopathy : fibrinolysis D-dimers	µg/L	Day 3
Secondary	biological AAS coagulopathy : fibrinolysis D-dimers	µg/L	Day 7
Secondary	hospitalisation duration	number of days	hospital discharge
Secondary	impact of misdiagnosis and misdiagnosis-induced treatments	massive post-operative bleeding (BART definition)	Day 2
Secondary	impact of misdiagnosis and misdiagnosis-induced treatments	massive post-operative bleeding (BART definition)	Day 7
Secondary	platelets dysfunction	platelets rate G/L	day 1
Secondary	platelets dysfunction	platelets rate G/L	day 2
Secondary	platelets dysfunction	platelets rate G/L	day 3
Secondary	platelets dysfunction	platelets rate G/L	day 7
Secondary	platelets dysfunction	CD 40 L pg/mL	baseline
Secondary	endotheliopathy	IL6 rate pg/mL	baseline
Secondary	endotheliopathy	IL8 rate pg/mL	baseline
Secondary	endotheliopathy	syndecan rate pg/mL	baseline
Secondary	endotheliopathy	endocan rate pg/mL	baseline
Secondary	endotheliopathy	angiopoietine 2 rate ng/mL	baseline
Secondary	endotheliopathy	angiopoietine 2 / angiopoietine 2 ratio	baseline
Secondary	endotheliopathy	VEGF ng/mL	baseline
Secondary	endotheliopathy	FGF basic ng/mL	baseline
Secondary	symptoms-surgery delay	time hours	baseline
Secondary	clinical severity shock	acidosis pH	baseline
Secondary	clinical severity shock	lactate level (mmol/L)	baseline
Secondary	clinical severity shock	number of organs with malperfusion (number)	baseline