Packed Red Blood Cell Transfusion in Elective Coronary Ar... | NCT02585310

Studies
Packed Red Blood Cell Transfusion in Elective Coronary Artery Bypass Graft Surgery in A University Hospital

NCT02585310

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Oct 23, 2015Estimated

Enrollment

300Actual

Phase

Not provided

Conditions

PRBC Transfusion
CABGs

Interventions

Packed red blood cell transfusion

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

Oct 2015

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

Nov 2011

Primary Completion Date

Sep 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Oct 21, 2015

First Submission Date that Met QC Criteria

Oct 21, 2015

First Posted Date

Oct 23, 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

Oct 21, 2015

Last Update Posted Date

Oct 23, 2015Estimated

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

In Siriraj Hospital, blood consumption in Cardiac surgery is high (units per patient) and frequent (number of patients receiving blood). The incidence of side effects are unknown, as is the exact amount of blood used/provided for patients with elective CABGs.

The primary objective of this study was to demonstrate the incidence of packed red blood cell (PRBC) transfusion in elective CABGs.

Detailed Description

Three hundred patients undergoing isolated, first time CABGs during November 2011-September 2013 were prospective enrolled in this observational study. Patients' preoperative variables and postoperative outcomes, as well as perioperative transfusion characteristics were recorded.

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

300Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Packed red blood cell transfusion	Other	Record number of PRBC transfusion during perioperative period.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of PRBC transfusion in elective CABG surgery		14 days

Secondary Outcomes

Measure	Description	Time Frame
risk factors of PRBC transfusion in elective CABG surgery		14 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients undergoing first-time isolated elective coronary artery bypass graft surgery

Exclusion Criteria:

None

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 CABGs

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sirilak Suksompong, MD	Mahidol University	Principal Investigator

Locations

Not provided