Coagulopathy in Acute Aortic Syndrome (SAACAOG)

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

Study Overview

• Status: Recruiting
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Diane Zlotnik, MD; Phone Number: +33156092428; Email: diane.zlotnik@aphp.fr
• Study Contact Backup: Name: Anne Godier, MD-PhD; Phone Number: +33156092584; Email: anne.godier@aphp.fr

Study Locations

• France
  • Paris, France
    • Recruiting
    • Université de Paris
    • Contact: Anne Godier, MD-PhD; Phone Number: +33156092584; Email: anne.godier@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Acute aortic syndrome; patients admitted to the Georges Pompidou European Hospital via the "SOS aorta" network

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: European Georges Pompidou Hospital
• Investigators: Principal Investigator: Diane Zlotnik, MD, European Georges Pompidou Hospital; Study Chair: Anne Godier, MD-PhD, European Georges Pompidou Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: November 25, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: November 25, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Coagulopathy; Blood transfusion; Acute aortic dissection
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders
• Other Study ID Numbers: SAACOAG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: we will maybe try later to make a multicentric descriptive analysis with other french hospitals

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No