NCT02859662

Brief Summary

It is an observational study on ruptured abdominal aortic aneurysm and abdominal compartment syndrome. the aim of this study is to assess the qualities of a predictive score on the occurence of this syndrome after surgery of ruptured aortic aneurysm

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
23 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

November 7, 2017

Status Verified

November 1, 2017

Enrollment Period

2.5 years

First QC Date

May 9, 2016

Last Update Submit

November 6, 2017

Conditions

Keywords

abdominal compartment syndromeabdominal aortic aneurysmruptured aneurysm

Outcome Measures

Primary Outcomes (1)

  • a predictive score on the appearance of an abdominal compartment syndrome after a surgical treatment of a ruptured abdominal aortic aneurysm

    score with criteria

    30 days

Secondary Outcomes (2)

  • 30 days mortality rate

    30 days

  • the duration of hospitalisation (intensive care unit stay and total hospital stay)

    30 days

Interventions

All patients with ruptured abdominal aortic aneurysm may be included in this study, whatever the surgical treatment.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with ruptured abdominal aortic aneurysm may be included in the study, whatever the surgical technique used.

You may qualify if:

  • over 18
  • to be hospitalized in participating hospitals
  • ruptured aneurysm confirmed and operated

You may not qualify if:

  • pregnancy
  • patients with bladder tumor or bladder surgery or trauma bladder can distort bladder pressure measurement
  • cystectomy
  • patients died before arrival in the operating room
  • patients died during surgery or within one hour of the initial surgical procedure
  • patient whose abdominal closure at the end of the procedure is impossible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

CHU

Bordeaux, France

RECRUITING

CHU

Clermont-Ferrand, France

RECRUITING

CH

Colmar, France

RECRUITING

CHU

Dijon, France

RECRUITING

CHU

Lyon, France

RECRUITING

CH

Mulhouse, France

RECRUITING

CHU

Nancy, France

RECRUITING

CHU

Nantes, France

RECRUITING

CHU

Rennes, France

RECRUITING

CHU Strasbourg

Strasbourg, France

RECRUITING

Related Publications (1)

  • Leclerc B, Salomon Du Mont L, Parmentier AL, Besch G, Rinckenbach S. Abdominal compartment syndrome and ruptured aortic aneurysm: Validation of a predictive test (SCA-AAR). Medicine (Baltimore). 2018 Jun;97(25):e11066. doi: 10.1097/MD.0000000000011066.

MeSH Terms

Conditions

Intra-Abdominal HypertensionAortic Aneurysm, AbdominalAneurysm, Ruptured

Condition Hierarchy (Ancestors)

Compartment SyndromesMuscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular DiseasesAortic AneurysmAneurysmAortic Diseases

Study Officials

  • Simon Rinckenbach, MD PhD

    CHRU Besancon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Rinckenbach, MD PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2016

First Posted

August 9, 2016

Study Start

September 1, 2016

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

November 7, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations