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
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienkontakt
- Name: Diane Zlotnik, MD
- Telefonnummer: +33156092428
- E-Mail: diane.zlotnik@aphp.fr
Studieren Sie die Kontaktsicherung
- Name: Anne Godier, MD-PhD
- Telefonnummer: +33156092584
- E-Mail: anne.godier@aphp.fr
Studienorte
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Paris, Frankreich
- Rekrutierung
- Université de Paris
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Kontakt:
- Anne Godier, MD-PhD
- Telefonnummer: +33156092584
- E-Mail: anne.godier@aphp.fr
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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total transfusion requirements
Zeitfenster: Day 2
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red blood cells units (number)
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Day 2
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death from AAS
Zeitfenster: Day 30
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probability of Survival (pourcentage %)
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Day 30
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coagulopathy rTQ > 1.2 incidence
Zeitfenster: baseline
|
pourcentage %
|
baseline
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
total transfusion requirements
Zeitfenster: Day 1
|
red blood cell unit, fresh frozen plasma and platelets units (number)
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Day 1
|
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total transfusion requirements
Zeitfenster: Day 2
|
red blood cell unit, fresh frozen plasma and platelets units (number)
|
Day 2
|
|
total transfusion requirements
Zeitfenster: Day 3
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red blood cell unit, fresh frozen plasma and platelets units
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Day 3
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total transfusion requirements
Zeitfenster: Day 7
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red blood cell unit, fresh frozen plasma and platelets units
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Day 7
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biological AAS coagulopathy : coagulation factors consumption
Zeitfenster: Day 1, Day 2, Day 3, Day 7
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pourcentage %
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Day 1, Day 2, Day 3, Day 7
|
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biological AAS coagulopathy : coagulation factors consumption
Zeitfenster: Day 2
|
pourcentage %
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Day 2
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biological AAS coagulopathy : coagulation factors consumption
Zeitfenster: Day 3
|
pourcentage %
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Day 3
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biological AAS coagulopathy : coagulation factors consumption
Zeitfenster: Day 7
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pourcentage %
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Day 7
|
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biological AAS coagulopathy : fibrinolysis D-dimers
Zeitfenster: Day 1
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µg/L
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Day 1
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biological AAS coagulopathy : fibrinolysis D-dimers
Zeitfenster: Day 2
|
µg/L
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Day 2
|
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biological AAS coagulopathy : fibrinolysis D-dimers
Zeitfenster: Day 3
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µg/L
|
Day 3
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biological AAS coagulopathy : fibrinolysis D-dimers
Zeitfenster: Day 7
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µg/L
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Day 7
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hospitalisation duration
Zeitfenster: hospital discharge
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number of days
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hospital discharge
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impact of misdiagnosis and misdiagnosis-induced treatments
Zeitfenster: Day 2
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massive post-operative bleeding (BART definition)
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Day 2
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impact of misdiagnosis and misdiagnosis-induced treatments
Zeitfenster: Day 7
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massive post-operative bleeding (BART definition)
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Day 7
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platelets dysfunction
Zeitfenster: day 1
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platelets rate G/L
|
day 1
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platelets dysfunction
Zeitfenster: day 2
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platelets rate G/L
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day 2
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platelets dysfunction
Zeitfenster: day 3
|
platelets rate G/L
|
day 3
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platelets dysfunction
Zeitfenster: day 7
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platelets rate G/L
|
day 7
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platelets dysfunction
Zeitfenster: baseline
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CD 40 L pg/mL
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baseline
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endotheliopathy
Zeitfenster: baseline
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IL6 rate pg/mL
|
baseline
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endotheliopathy
Zeitfenster: baseline
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IL8 rate pg/mL
|
baseline
|
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endotheliopathy
Zeitfenster: baseline
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syndecan rate pg/mL
|
baseline
|
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endotheliopathy
Zeitfenster: baseline
|
endocan rate pg/mL
|
baseline
|
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endotheliopathy
Zeitfenster: baseline
|
angiopoietine 2 rate ng/mL
|
baseline
|
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endotheliopathy
Zeitfenster: baseline
|
angiopoietine 2 / angiopoietine 2 ratio
|
baseline
|
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endotheliopathy
Zeitfenster: baseline
|
VEGF ng/mL
|
baseline
|
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endotheliopathy
Zeitfenster: baseline
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FGF basic ng/mL
|
baseline
|
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symptoms-surgery delay
Zeitfenster: baseline
|
time hours
|
baseline
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clinical severity shock
Zeitfenster: baseline
|
acidosis pH
|
baseline
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clinical severity shock
Zeitfenster: baseline
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lactate level (mmol/L)
|
baseline
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clinical severity shock
Zeitfenster: baseline
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number of organs with malperfusion (number)
|
baseline
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Diane Zlotnik, MD, European Georges Pompidou Hospital
- Studienstuhl: Anne Godier, MD-PhD, European Georges Pompidou Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- SAACOAG
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