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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Diane Zlotnik, MD
- Telefonnummer: +33156092428
- E-mail: diane.zlotnik@aphp.fr
Undersøgelse Kontakt Backup
- Navn: Anne Godier, MD-PhD
- Telefonnummer: +33156092584
- E-mail: anne.godier@aphp.fr
Studiesteder
-
-
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Paris, Frankrig
- Rekruttering
- Université de Paris
-
Kontakt:
- Anne Godier, MD-PhD
- Telefonnummer: +33156092584
- E-mail: anne.godier@aphp.fr
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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Acute aortic syndrome
patients admitted to the Georges Pompidou European Hospital via the "SOS aorta" network
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
total transfusion requirements
Tidsramme: Day 2
|
red blood cells units (number)
|
Day 2
|
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death from AAS
Tidsramme: Day 30
|
probability of Survival (pourcentage %)
|
Day 30
|
|
coagulopathy rTQ > 1.2 incidence
Tidsramme: baseline
|
pourcentage %
|
baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
total transfusion requirements
Tidsramme: Day 1
|
red blood cell unit, fresh frozen plasma and platelets units (number)
|
Day 1
|
|
total transfusion requirements
Tidsramme: Day 2
|
red blood cell unit, fresh frozen plasma and platelets units (number)
|
Day 2
|
|
total transfusion requirements
Tidsramme: Day 3
|
red blood cell unit, fresh frozen plasma and platelets units
|
Day 3
|
|
total transfusion requirements
Tidsramme: Day 7
|
red blood cell unit, fresh frozen plasma and platelets units
|
Day 7
|
|
biological AAS coagulopathy : coagulation factors consumption
Tidsramme: Day 1, Day 2, Day 3, Day 7
|
pourcentage %
|
Day 1, Day 2, Day 3, Day 7
|
|
biological AAS coagulopathy : coagulation factors consumption
Tidsramme: Day 2
|
pourcentage %
|
Day 2
|
|
biological AAS coagulopathy : coagulation factors consumption
Tidsramme: Day 3
|
pourcentage %
|
Day 3
|
|
biological AAS coagulopathy : coagulation factors consumption
Tidsramme: Day 7
|
pourcentage %
|
Day 7
|
|
biological AAS coagulopathy : fibrinolysis D-dimers
Tidsramme: Day 1
|
µg/L
|
Day 1
|
|
biological AAS coagulopathy : fibrinolysis D-dimers
Tidsramme: Day 2
|
µg/L
|
Day 2
|
|
biological AAS coagulopathy : fibrinolysis D-dimers
Tidsramme: Day 3
|
µg/L
|
Day 3
|
|
biological AAS coagulopathy : fibrinolysis D-dimers
Tidsramme: Day 7
|
µg/L
|
Day 7
|
|
hospitalisation duration
Tidsramme: hospital discharge
|
number of days
|
hospital discharge
|
|
impact of misdiagnosis and misdiagnosis-induced treatments
Tidsramme: Day 2
|
massive post-operative bleeding (BART definition)
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Day 2
|
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impact of misdiagnosis and misdiagnosis-induced treatments
Tidsramme: Day 7
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massive post-operative bleeding (BART definition)
|
Day 7
|
|
platelets dysfunction
Tidsramme: day 1
|
platelets rate G/L
|
day 1
|
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platelets dysfunction
Tidsramme: day 2
|
platelets rate G/L
|
day 2
|
|
platelets dysfunction
Tidsramme: day 3
|
platelets rate G/L
|
day 3
|
|
platelets dysfunction
Tidsramme: day 7
|
platelets rate G/L
|
day 7
|
|
platelets dysfunction
Tidsramme: baseline
|
CD 40 L pg/mL
|
baseline
|
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endotheliopathy
Tidsramme: baseline
|
IL6 rate pg/mL
|
baseline
|
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endotheliopathy
Tidsramme: baseline
|
IL8 rate pg/mL
|
baseline
|
|
endotheliopathy
Tidsramme: baseline
|
syndecan rate pg/mL
|
baseline
|
|
endotheliopathy
Tidsramme: baseline
|
endocan rate pg/mL
|
baseline
|
|
endotheliopathy
Tidsramme: baseline
|
angiopoietine 2 rate ng/mL
|
baseline
|
|
endotheliopathy
Tidsramme: baseline
|
angiopoietine 2 / angiopoietine 2 ratio
|
baseline
|
|
endotheliopathy
Tidsramme: baseline
|
VEGF ng/mL
|
baseline
|
|
endotheliopathy
Tidsramme: baseline
|
FGF basic ng/mL
|
baseline
|
|
symptoms-surgery delay
Tidsramme: baseline
|
time hours
|
baseline
|
|
clinical severity shock
Tidsramme: baseline
|
acidosis pH
|
baseline
|
|
clinical severity shock
Tidsramme: baseline
|
lactate level (mmol/L)
|
baseline
|
|
clinical severity shock
Tidsramme: baseline
|
number of organs with malperfusion (number)
|
baseline
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Diane Zlotnik, MD, European Georges Pompidou Hospital
- Studiestol: Anne Godier, MD-PhD, European Georges Pompidou Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SAACOAG
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
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