An observational study in Coagulopathy, sponsored by European Georges Pompidou Hospital. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-08.
Sponsored by European Georges Pompidou Hospital · Observational
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
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.
503 studies on the registry are indexed under Hemostatic Disorders; 71 are open to participants now.
This study's planned enrollment of 500 is above the median of 100 across 229 observational studies indexed under Hemostatic Disorders.
Browse Hemostatic Disorders studies →European Georges Pompidou Hospital is the lead sponsor of 23 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
patients admitted to the Georges Pompidou European Hospital via the "SOS aorta" network
total transfusion requirements
red blood cells units (number)
Time frame: Day 2
death from AAS
probability of Survival (pourcentage %)
Time frame: Day 30
coagulopathy rTQ > 1.2 incidence
pourcentage %
Time frame: baseline
total transfusion requirements
red blood cell unit, fresh frozen plasma and platelets units (number)
Time frame: Day 1
total transfusion requirements
red blood cell unit, fresh frozen plasma and platelets units (number)
Time frame: Day 2
total transfusion requirements
red blood cell unit, fresh frozen plasma and platelets units
Time frame: Day 3
total transfusion requirements
red blood cell unit, fresh frozen plasma and platelets units
Time frame: Day 7
biological AAS coagulopathy : coagulation factors consumption
pourcentage %
Time frame: Day 1, Day 2, Day 3, Day 7
biological AAS coagulopathy : coagulation factors consumption
pourcentage %
Time frame: Day 2
biological AAS coagulopathy : coagulation factors consumption
pourcentage %
Time frame: Day 3
biological AAS coagulopathy : coagulation factors consumption
pourcentage %
Time frame: Day 7
biological AAS coagulopathy : fibrinolysis D-dimers
µg/L
Time frame: Day 1
biological AAS coagulopathy : fibrinolysis D-dimers
µg/L
Time frame: Day 2
biological AAS coagulopathy : fibrinolysis D-dimers
µg/L
Time frame: Day 3
biological AAS coagulopathy : fibrinolysis D-dimers
µg/L
Time frame: Day 7
hospitalisation duration
number of days
Time frame: hospital discharge
impact of misdiagnosis and misdiagnosis-induced treatments
massive post-operative bleeding (BART definition)
Time frame: Day 2
impact of misdiagnosis and misdiagnosis-induced treatments
massive post-operative bleeding (BART definition)
Time frame: Day 7
platelets dysfunction
platelets rate G/L
Time frame: day 1
platelets dysfunction
platelets rate G/L
Time frame: day 2
platelets dysfunction
platelets rate G/L
Time frame: day 3
platelets dysfunction
platelets rate G/L
Time frame: day 7
platelets dysfunction
CD 40 L pg/mL
Time frame: baseline
endotheliopathy
IL6 rate pg/mL
Time frame: baseline
endotheliopathy
IL8 rate pg/mL
Time frame: baseline
endotheliopathy
syndecan rate pg/mL
Time frame: baseline
endotheliopathy
endocan rate pg/mL
Time frame: baseline
endotheliopathy
angiopoietine 2 rate ng/mL
Time frame: baseline
endotheliopathy
angiopoietine 2 / angiopoietine 2 ratio
Time frame: baseline
endotheliopathy
VEGF ng/mL
Time frame: baseline
endotheliopathy
FGF basic ng/mL
Time frame: baseline
symptoms-surgery delay
time hours
Time frame: baseline
clinical severity shock
acidosis pH
Time frame: baseline
clinical severity shock
lactate level (mmol/L)
Time frame: baseline
clinical severity shock
number of organs with malperfusion (number)
Time frame: baseline
Plan to share: Undecided — we will maybe try later to make a multicentric descriptive analysis with other french hospitals
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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European Georges Pompidou Hospital