Coagulopathy in Acute Aortic Syndrome (SAACAOG)

November 25, 2021 updated by: Diane Zlotnik, European Georges Pompidou Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Paris, France
        • Recruiting
        • Université de Paris
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Acute aortic syndrome
patients admitted to the Georges Pompidou European Hospital via the "SOS aorta" network

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
total transfusion requirements
Time Frame: Day 2
red blood cells units (number)
Day 2
death from AAS
Time Frame: Day 30
probability of Survival (pourcentage %)
Day 30
coagulopathy rTQ > 1.2 incidence
Time Frame: baseline
pourcentage %
baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
total transfusion requirements
Time Frame: Day 1
red blood cell unit, fresh frozen plasma and platelets units (number)
Day 1
total transfusion requirements
Time Frame: Day 2
red blood cell unit, fresh frozen plasma and platelets units (number)
Day 2
total transfusion requirements
Time Frame: Day 3
red blood cell unit, fresh frozen plasma and platelets units
Day 3
total transfusion requirements
Time Frame: Day 7
red blood cell unit, fresh frozen plasma and platelets units
Day 7
biological AAS coagulopathy : coagulation factors consumption
Time Frame: Day 1, Day 2, Day 3, Day 7
pourcentage %
Day 1, Day 2, Day 3, Day 7
biological AAS coagulopathy : coagulation factors consumption
Time Frame: Day 2
pourcentage %
Day 2
biological AAS coagulopathy : coagulation factors consumption
Time Frame: Day 3
pourcentage %
Day 3
biological AAS coagulopathy : coagulation factors consumption
Time Frame: Day 7
pourcentage %
Day 7
biological AAS coagulopathy : fibrinolysis D-dimers
Time Frame: Day 1
µg/L
Day 1
biological AAS coagulopathy : fibrinolysis D-dimers
Time Frame: Day 2
µg/L
Day 2
biological AAS coagulopathy : fibrinolysis D-dimers
Time Frame: Day 3
µg/L
Day 3
biological AAS coagulopathy : fibrinolysis D-dimers
Time Frame: Day 7
µg/L
Day 7
hospitalisation duration
Time Frame: hospital discharge
number of days
hospital discharge
impact of misdiagnosis and misdiagnosis-induced treatments
Time Frame: Day 2
massive post-operative bleeding (BART definition)
Day 2
impact of misdiagnosis and misdiagnosis-induced treatments
Time Frame: Day 7
massive post-operative bleeding (BART definition)
Day 7
platelets dysfunction
Time Frame: day 1
platelets rate G/L
day 1
platelets dysfunction
Time Frame: day 2
platelets rate G/L
day 2
platelets dysfunction
Time Frame: day 3
platelets rate G/L
day 3
platelets dysfunction
Time Frame: day 7
platelets rate G/L
day 7
platelets dysfunction
Time Frame: baseline
CD 40 L pg/mL
baseline
endotheliopathy
Time Frame: baseline
IL6 rate pg/mL
baseline
endotheliopathy
Time Frame: baseline
IL8 rate pg/mL
baseline
endotheliopathy
Time Frame: baseline
syndecan rate pg/mL
baseline
endotheliopathy
Time Frame: baseline
endocan rate pg/mL
baseline
endotheliopathy
Time Frame: baseline
angiopoietine 2 rate ng/mL
baseline
endotheliopathy
Time Frame: baseline
angiopoietine 2 / angiopoietine 2 ratio
baseline
endotheliopathy
Time Frame: baseline
VEGF ng/mL
baseline
endotheliopathy
Time Frame: baseline
FGF basic ng/mL
baseline
symptoms-surgery delay
Time Frame: baseline
time hours
baseline
clinical severity shock
Time Frame: baseline
acidosis pH
baseline
clinical severity shock
Time Frame: baseline
lactate level (mmol/L)
baseline
clinical severity shock
Time Frame: baseline
number of organs with malperfusion (number)
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
European Georges Pompidou Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Diane Zlotnik, MD, European Georges Pompidou Hospital
  • Study Chair: Anne Godier, MD-PhD, European Georges Pompidou Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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