Decreased Consumption of Blood Components During Cardiac... | NCT02513966

Studies
Decreased Consumption of Blood Components During Cardiac Surgery Procedures: Causes and Effects.

NCT02513966

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Last Update Posted

Jun 27, 2024Actual

Enrollment

7,835Actual

Phase

Not provided

Conditions

Blood Safety
Blood Transfusion

Interventions

Not provided

Countries

Not provided

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

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

May 17, 2022Actual

Completion Date

May 18, 2022Actual

First Submitted Date

Jul 13, 2015

First Submission Date that Met QC Criteria

Jul 31, 2015

First Posted Date

Aug 3, 2015Estimated

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

Jun 26, 2024

Last Update Posted Date

Jun 27, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

There is a decrease in the amount of blood components used during cardiac surgery in the last four years. As the hemovigilance team of the investigators' Hospital the investigators want to find out the causes and effects of this decrease.

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

7,835Actual

Measure	Description	Time Frame
amount of blood use during Cardiac surgery		5years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient underwent cardiac surgery between 2010 and 2014 in UZ Leuven

Exclusion Criteria:

patient without cardiac surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients undergoing cardiac surgery from 2010 untill 2014 in the University Hospitals of Leuven.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Timothy Devos, master	Universitaire Ziekenhuizen KU Leuven	Study Chair

Locations

Not provided