Impact of Transfusional Practice on the Morbidity and Mor... | NCT03934112

Studies
Impact of Transfusional Practice on the Morbidity and Mortality of Patients in Intensive Care Unit

NCT03934112

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Recruiting

Last Update Posted

Sep 19, 2024Actual

Enrollment

150,000Estimated

Phase

Not provided

Conditions

Transfusion Related Complication

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 3, 2020Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Apr 26, 2019

First Submission Date that Met QC Criteria

Apr 30, 2019

First Posted Date

May 1, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2024

Last Update Posted Date

Sep 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will allow correlating transfusion monitoring and patients' prognostic according to the chosen outcome criteria.

These data could thus represent a basis for transfusion recommendations, except for intensive care and vital emergencies.

It will also bring information about the actual transfusion monitoring in intensive care unit (ICU), in the period following the stay in the ICU and after hospital discharge.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival at 90 days after leaving ICU	All-cause mortality 90 days after leaving ICU	Day 90

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Patient admitted to medical and surgical resuscitation units of Besançon and Dijon university hospitals, all causes considered
Patient admitted between 1st January 2012 to 31st December 2017

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients treated in medical and surgical resuscitation units of Besançon and Dijon university hospitals during the study period (from 01/01/2012 to 31/12/2017) are concerned.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maxime Desmarets, PhD	Contact	0033 381 218 359		maxime.desmarets@univ-fcomte.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Besançon	Recruiting	Besançon			France