CoagulopathySAACAOGNCT05149261
Coagulopathy in Acute Aortic Syndrome
An observational study of Coagulopathy, run by European Georges Pompidou Hospital at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coagulopathy
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2019to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- admitted to hospital via the "SOS Aorta" network for acute aortic syndrome (AAS) suspicion
Who cannot join
- aged < 18y
- pregnant women
- no social security
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Université de Paris
Paris
Anne Godier, MD-PhD, +33156092584, anne.godier@aphp.fr
About this study
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
Read the 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.
- Conditions
- Coagulopathy
- Keywords
- Coagulopathy, Acute aortic dissection, Blood transfusion
- Medical subject headings
- Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute aortic syndrome | patients admitted to the Georges Pompidou European Hospital via the "SOS aorta" network |
What is being measured
The primary outcome is the main question the study is designed to answer.
total transfusion requirements
red blood cells units (number)
Measured: Day 2
death from AAS
probability of Survival (pourcentage %)
Measured: Day 30
coagulopathy rTQ > 1.2 incidence
pourcentage %
Measured: baseline
Secondary outcomes (32)
total transfusion requirements
red blood cell unit, fresh frozen plasma and platelets units (number)
Measured: Day 1
total transfusion requirements
red blood cell unit, fresh frozen plasma and platelets units (number)
Measured: Day 2
total transfusion requirements
red blood cell unit, fresh frozen plasma and platelets units
Measured: Day 3
total transfusion requirements
red blood cell unit, fresh frozen plasma and platelets units
Measured: Day 7
biological AAS coagulopathy : coagulation factors consumption
pourcentage %
Measured: Day 1, Day 2, Day 3, Day 7
biological AAS coagulopathy : coagulation factors consumption
pourcentage %
Measured: Day 2
biological AAS coagulopathy : coagulation factors consumption
pourcentage %
Measured: Day 3
biological AAS coagulopathy : coagulation factors consumption
pourcentage %
Measured: Day 7
biological AAS coagulopathy : fibrinolysis D-dimers
µg/L
Measured: Day 1
biological AAS coagulopathy : fibrinolysis D-dimers
µg/L
Measured: Day 2
biological AAS coagulopathy : fibrinolysis D-dimers
µg/L
Measured: Day 3
biological AAS coagulopathy : fibrinolysis D-dimers
µg/L
Measured: Day 7
hospitalisation duration
number of days
Measured: hospital discharge
impact of misdiagnosis and misdiagnosis-induced treatments
massive post-operative bleeding (BART definition)
Measured: Day 2
impact of misdiagnosis and misdiagnosis-induced treatments
massive post-operative bleeding (BART definition)
Measured: Day 7
platelets dysfunction
platelets rate G/L
Measured: day 1
platelets dysfunction
platelets rate G/L
Measured: day 2
platelets dysfunction
platelets rate G/L
Measured: day 3
platelets dysfunction
platelets rate G/L
Measured: day 7
platelets dysfunction
CD 40 L pg/mL
Measured: baseline
endotheliopathy
IL6 rate pg/mL
Measured: baseline
endotheliopathy
IL8 rate pg/mL
Measured: baseline
endotheliopathy
syndecan rate pg/mL
Measured: baseline
endotheliopathy
endocan rate pg/mL
Measured: baseline
endotheliopathy
angiopoietine 2 rate ng/mL
Measured: baseline
endotheliopathy
angiopoietine 2 / angiopoietine 2 ratio
Measured: baseline
endotheliopathy
VEGF ng/mL
Measured: baseline
endotheliopathy
FGF basic ng/mL
Measured: baseline
symptoms-surgery delay
time hours
Measured: baseline
clinical severity shock
acidosis pH
Measured: baseline
clinical severity shock
lactate level (mmol/L)
Measured: baseline
clinical severity shock
number of organs with malperfusion (number)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start1 Jul 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoagulopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Georges Pompidou Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diane Zlotnik, European Georges Pompidou Hospital
- Investigators
- Diane Zlotnik, MD, Principal investigator, European Georges Pompidou HospitalAnne Godier, MD-PhD, Study chair, European Georges Pompidou Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149261
- Sponsor's protocol ID
- SAACOAG
- Acronym
- SAACAOG
- Status last verified
- Nov 2021
- First submitted
- 8 Nov 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: we will maybe try later to make a multicentric descriptive analysis with other french hospitals
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coagulopathy in Acute Aortic Syndrome
- ClinicalTrials.gov ID
- NCT05149261
- Acronym / sponsor ID
- SAACAOG / SAACOAG
- Conditions
- Coagulopathy
- Keywords
- Coagulopathy, Acute aortic dissection, Blood transfusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- European Georges Pompidou HospitalUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute aortic syndrome | – | –patients admitted to the Georges Pompidou European Hospital via the "SOS aorta" network |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- admitted to hospital via the "SOS Aorta" network for acute aortic syndrome (AAS) suspicion
Key exclusion criteria (3 listed)
- aged < 18y
- pregnant women
- no social security
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
total transfusion requirements
Time frame: Day 2
red blood cells units (number)
death from AAS
Time frame: Day 30
probability of Survival (pourcentage %)
coagulopathy rTQ > 1.2 incidence
Time frame: baseline
pourcentage %
32 secondary outcomes
total transfusion requirements
Time frame: Day 1
total transfusion requirements
Time frame: Day 2
total transfusion requirements
Time frame: Day 3
total transfusion requirements
Time frame: Day 7
biological AAS coagulopathy : coagulation factors consumption
Time frame: Day 1, Day 2, Day 3, Day 7
biological AAS coagulopathy : coagulation factors consumption
Time frame: Day 2
biological AAS coagulopathy : coagulation factors consumption
Time frame: Day 3
biological AAS coagulopathy : coagulation factors consumption
Time frame: Day 7
biological AAS coagulopathy : fibrinolysis D-dimers
Time frame: Day 1
biological AAS coagulopathy : fibrinolysis D-dimers
Time frame: Day 2
biological AAS coagulopathy : fibrinolysis D-dimers
Time frame: Day 3
biological AAS coagulopathy : fibrinolysis D-dimers
Time frame: Day 7
hospitalisation duration
Time frame: hospital discharge
impact of misdiagnosis and misdiagnosis-induced treatments
Time frame: Day 2
impact of misdiagnosis and misdiagnosis-induced treatments
Time frame: Day 7
platelets dysfunction
Time frame: day 1
platelets dysfunction
Time frame: day 2
platelets dysfunction
Time frame: day 3
platelets dysfunction
Time frame: day 7
platelets dysfunction
Time frame: baseline
endotheliopathy
Time frame: baseline
endotheliopathy
Time frame: baseline
endotheliopathy
Time frame: baseline
endotheliopathy
Time frame: baseline
endotheliopathy
Time frame: baseline
endotheliopathy
Time frame: baseline
endotheliopathy
Time frame: baseline
endotheliopathy
Time frame: baseline
symptoms-surgery delay
Time frame: baseline
clinical severity shock
Time frame: baseline
clinical severity shock
Time frame: baseline
clinical severity shock
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Individual participant dataSharing planned: Undecided. we will maybe try later to make a multicentric descriptive analysis with other french hospitals
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diane Zlotnik, MD principal investigator
European Georges Pompidou Hospital
Anne Godier, MD-PhD study chair
European Georges Pompidou Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coagulopathy, run by European Georges Pompidou Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diane Zlotnik, MD (+33156092428, diane.zlotnik@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total transfusion requirements (time frame: Day 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021; AzTrials last refreshed its copy on 1 Nov 2026.