Blood Management Program in the Post - Operative Period. | NCT02149069

Studies
Blood Management Program in the Post - Operative Period.

NCT02149069

Sponsor

Azienda USL Reggio Emilia - IRCCS

Status

Unknown status

Last Update Posted

Aug 3, 2015Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Excessive Amount of Blood / Fluid Transfusion

Interventions

Not provided

Countries

Italy

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Dec 2015Estimated

Completion Date

Jan 2016Estimated

First Submitted Date

May 26, 2014

First Submission Date that Met QC Criteria

May 28, 2014

First Posted Date

May 29, 2014Estimated

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

Jul 31, 2015

Last Update Posted Date

Aug 3, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

PAMELABERNI, Data Manager, Azienda USL Reggio Emilia - IRCCSPrincipal Investigator

Lead Sponsor

Azienda USL Reggio Emilia - IRCCSOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

A care path in the field of transfusion medicine was creates at ASMN - IRCCS addressed to patients undergoing complex surgical procedures.

Detailed Description

This pathway is called Blood Management Program (BMP).

The implementation of this process should improve transfusion therapy in the peri-operative period in order to:

correct the transfusional approach to surgical patients
optimize the management of transfusional resources (red blood cells, plasma, platelets)
optimize the management of plasma derivatives, drugs and techniques designed to limit the use of homologous blood

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

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of therapeutic appropriateness for Red Cells - Plasma - Platelets transfusion: comparison between prospective vs. retrospective data in ASMN ,Reggio Emilia (Italy)		24 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

-All patients undergoing complex surgical procedures

Exclusion Criteria:

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

patients undergoing complex surgical procedures

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Berni Pamela, Doctor	Contact	0039-0522-295601		pamela.berni@asmn.re.it

Overall Officials

Name	Affiliation	Role
Erminia Di Bartolomeo, MD	ASMN-IRCCS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS-Arcispedale Santa Maria Nuova	Recruiting	Reggio Emilia	Emilia-Romagna	42123	Italy

Type	Date	Date Unknown
Release	Jul 14, 2016
Reset	Aug 25, 2016
Release	Sep 19, 2016
Reset	Nov 4, 2016
Release	Feb 1, 2018
Reset	Oct 26, 2018
Release	Jun 23, 2025
Reset	Jul 10, 2025

Submission Tracking

Estimated Results First Submitted Date

Jul 14, 2016

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 14, 2016			Aug 25, 2016
Sep 19, 2016