FFDA: Pre-hospital Management of Aortic Dissection

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Unknown status
CT.gov ID
NCT04304443
Collaborator
Hopital Nord Franche-Comte (Other), Centre Hospitalier de Lons Le Saunier (Other), Centre hospitalier de Vesoul (Other), Centre hospitalier de Pontarlier (Other), Centre hospitalier de Gray (Other), Centre hospitalier de Dole (Other), Centre Hospitalier de Saint-Claude (Other)
300
2
4
150
37.4

Study Details

Study Description

Brief Summary

Background :

Time between symptoms onset and treatment initiation is crucial in Acute aortic dissection (AAD). An anti-hypertensive treatment can be rapidly initiated before the arrival in Emergency Department (ED). A better understanding of the chain of care between symptoms onset and surgery could lead to a reduction of morbi-mortality. Our study have the objective to describe the chain of care of patients with AAD in the ED.

Methods :

This is an observational, retrospective, multicenter study. Patients were detected with a discharge of diagnostic of aortic dissection (ICD I71.0) in university medical center of Besançon. Data collection : patients records in the 8 hospitals centers of the area Franche-Comté.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Acute aortic dissection (AAD) is the most lethal vascular emergency. AAD remains a challenge to diagnose and to treat even for experienced practitioners. AAD identification and treatment administration greatly improve morbidity and mortality associated to AAD. The diagnosis of AAD is particularly challenging, due to a combination of highly heterogeneous clinical presentation and low incidence (3-5 cases/100,000 individuals/year). Clinical guidelines suggest that AAD should be considered in all patients presenting with chest pain, back pain, abdominal pain, syncope or symptoms consistent with perfusion deficit, but these symptoms account for large proportions of emergency medical visits. CT-scan is validated and increasedly available for confirming or ruling out AAD. Stanford classification is most current use, with two groups : type A involve the ascending aorta, type B don't involve the ascending aorta until the arch. The majority of type A is managed surgically, but the majority of type B is managed medically with anti-hypertensive treatment. Aortic dissection can be classified into hyperacute (from symptom onset to 24 hours), acute (2-7 days), subacute (8-30 days), and chronic (> 30 days). Booher et al, suggested that acute and sub-acute aortic dissection make the majority of the mortality rate.

    Mortality among patients with a Stanfond Type A dissection is 1 to 2 percent per hour, early after symptom onset. In-hospital mortality is highly dependent on patient risk profiles before surgery. Patient with a history of aortic valve replacement, a migrating chest pain, a tamponade, an hypotension or a limb ischemia are associated to a higher in-hospital mortality.

    Time between symptoms onset and treatment initiation is crucial. The diagnosis can be suspected by the family physician. In France, diagnosis can be also suspected by the MICU (Mobile Intensive Care Unit). An anti-hypertensive treatment can be rapidly initiated before the arrival by the ED, and the diagnosis is confirmed by CT-scan. In the Harris' study, median time from arrival at the emergency department to diagnosis and from diagnosis to surgery were 4.3 hours. To our knowledge no study investigated the pre-hospital phase, especially the impact of the methods and vectors used. A better understanding of the chain of care from symptoms onset to surgery could lead to a reduction of morbi-mortality. Our study aimed the objective to describe the chain of care of patients with AAD in the ED of eight hospitals centers of area of Franche-Comté (France) between 2010 and 2019.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Non Traumatic Aortic Dissection : Chain of Care and Pre-hospital Risk Factors, a Retrospective, Multicenter Study
    Actual Study Start Date :
    Mar 1, 2020
    Anticipated Primary Completion Date :
    May 1, 2020
    Anticipated Study Completion Date :
    Jul 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Mortality rate [30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria :
    • patients with age > 18 years

    • patients with the diagnosis of non traumatic acute aortic dissection

    • patients hospitalized in the university medical center

    Exclusion Criteria :
    • decision of withdrawal life support

    • patients that died without a diagnosis confirmation with Helical Computed Tomography (HCT), Magnetic Resonnance Imagery (MRI), TransEsophageal Echocardiography (TEE) or surgery/autopsy

    • AAD that were complications of coronarography or aortic surgery

    • lack of information

    • patient opposition to study participation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU de Besançon Besançon France 25000
    2 Hôpital Nord Franche-Comté Trévenans France 90400

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Besancon
    • Hopital Nord Franche-Comte
    • Centre Hospitalier de Lons Le Saunier
    • Centre hospitalier de Vesoul
    • Centre hospitalier de Pontarlier
    • Centre hospitalier de Gray
    • Centre hospitalier de Dole
    • Centre Hospitalier de Saint-Claude

    Investigators

    • Principal Investigator: Christian Daguerre, MD-student, CHU de Besançon
    • Study Director: Antoine Sigaux, MD, CHU de Besançon
    • Study Chair: Thibaut Desmettre, MD, PHD, CHU de Besançon

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Besancon
    ClinicalTrials.gov Identifier:
    NCT04304443
    Other Study ID Numbers:
    • P/2019/453
    First Posted:
    Mar 11, 2020
    Last Update Posted:
    Mar 23, 2020
    Last Verified:
    Feb 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Universitaire de Besancon
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 23, 2020