NCT02772913

Brief Summary

Acute mesenteric ischemia is a life-threatening condition characterized by high mortality if unrecognized early. This multicenter retrospective observational study will review the emergency departments's (ED) notes of all patients discharged from hospital with a diagnosis of acute mesenteric ischemia in 2014-2015 comparing it with those admitted to the ED for abdominal pain in the same timeframe.

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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 16, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

10 months

First QC Date

March 24, 2016

Last Update Submit

May 2, 2017

Conditions

Acute Mesenteric Ischemia

Outcome Measures

Primary Outcomes (1)

  • In-hospital mortality

    30 days from hospital admission

Secondary Outcomes (1)

  • in-hospital adverse outcome: cardiac arrest, ICU admission, septic shock, major bleeding.

    30 days from hospital admission

Study Arms (2)

acute mesenteric ischemia

patients with abdominal pain and acute mesenteric ischemia

non-acute mesenteric ischemia

patients with abdominal pain without mesenteric ischemia

Eligibility Criteria

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

Patients discharged from hospital with ICD-9 code related to acute mesenteric ischemia (1st cohort) compared with patients admitted for acute abdominal pain

You may qualify if:

  • ICD-9 diagnosis of acute mesenteric ischemia in 2014 and 2015
  • Admitted to hospital after Emergency Department assessment
  • age\>18

You may not qualify if:

  • age\<18
  • post-traumatic or post-surgery related acute mesenteric ischemia
  • lack of assessment in the Emergency Department

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS San Martino

Genoa, Liguria, 16132, Italy

RECRUITING

Study Officials

  • Vincenzo Savarino, Professor

    University of Genova

    STUDY CHAIR

Central Study Contacts

Stefano Sartini, MD

CONTACT

+39 3402638395stefano.sartini@asl3.liguria.it

Marcello Pastorelli, Professor

CONTACT

+39 0577586660marcello.pastorelli@unisi.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor, Consultant in Emergency Medicine

Study Record Dates

First Submitted

March 24, 2016

First Posted

May 16, 2016

Study Start

August 1, 2016

Primary Completion

June 1, 2017

Study Completion

October 1, 2017

Last Updated

May 5, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will share

Locations

IT(1)