NCT02896530

Brief Summary

Vascular complications in patients with inflammatory bowel disease (IBD), comprising mainly Crohn's disease (CD) and ulcerative colitis (UC), representing 2% extra-intestinal complications. In over 60% of cases, these vascular complications of deep venous thrombosis (DVT) or pulmonary embolism (PE). Several studies have shown that patients with IBD have a risk of venous thromboembolic disease (VTE) increased from 1.5 to 3.5. This risk is closely related to disease activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
Last Updated

September 12, 2016

Status Verified

September 1, 2016

Enrollment Period

1 month

First QC Date

August 31, 2016

Last Update Submit

September 6, 2016

Conditions

Arterial Thrombosis

Outcome Measures

Primary Outcomes (1)

  • Assessment of change of the number of thromboembolic events or venous or arterial

    Month 6, year 2

Secondary Outcomes (1)

  • Assessment of the relevance of anti thrombosis treatment

    Month 6, year 2

Interventions

No intervention. Description studyOTHER

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with arterial Thrombosis and Inflammatory Bowel Disease

You may qualify if:

  • Patients with arterial Thrombosis and Inflammatory Bowel Disease admitted in Paris Saint Joseph Hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2016

First Posted

September 12, 2016

Study Start

May 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 12, 2016

Record last verified: 2016-09

Locations

FR(1)