NCT03393169

Brief Summary

The local database results from a joint initiative of anesthesic, cardiology and cardiac surgery departements.Its purpose is to record in an exhaustive fashion all the interventions of cardiac surgery performed under extracorporeal circulation in adults at Bichat hospital.This database includes the preoperative characteristics of the patients, the type of surgery, the post-operative complications and the in-hospital mortality. The purpose of this observational study is to evaluate in-hospital morbidity and mortality for all types of cardiac surgery interventions and to analyze it according to the characteristics of the patients and the type of intervention.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
12,000

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress95%
Jan 2006Jun 2027

Study Start

First participant enrolled

January 1, 2006

Completed
11.3 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2017

Completed
8 months until next milestone

First Posted

Study publicly available on registry

January 8, 2018

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

January 8, 2018

Status Verified

December 1, 2017

Enrollment Period

20.4 years

First QC Date

May 2, 2017

Last Update Submit

January 2, 2018

Conditions

Cardiac Surgery Under Extra Corporeal Circulation

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    All-cause mortality is assessed during in-hospital stay and 30 days after the date of surgery

    30 days

Secondary Outcomes (8)

  • Postoperative organ failure

    30 days

  • Bleeding complications

    30 days

  • Arrhythmias

    30 days

  • Conductions disturbances

    30 days

  • Myocardial injury

    30 days

  • +3 more secondary outcomes

Eligibility Criteria

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

all patients , 18 years old and older, with a cardiac surgery under extra corporeal circulation in Bichat Hospital

You may qualify if:

  • years and older and has legal capacity - cardiac surgery under extra corporeal circulation
  • non objection to record medical information during hospitalization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

département de cardiologie et d'anesthésie réanimation Hôpital Bichat 46 rue Henri Huchard

Paris, 75018, France

RECRUITING

Study Officials

  • Bernard IUNG, MD.

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Central Study Contacts

Bernard IUNG, MD.

CONTACT

01 40 25 66 01bernard.Iung@aphp.fr

Sophie PROVENCHERE, MD.

CONTACT

01 40 25 51 11sophie.provenchere@aphp.fr

Study Design

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

Study Record Dates

First Submitted

May 2, 2017

First Posted

January 8, 2018

Study Start

January 1, 2006

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

January 8, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will share

with others French University Hospitals (Rennes, Nantes, Paris (PITIE SALPETRIERE) , Bordeaux)

Locations

FR(1)