An Analysis of Blood Management in Patients Having Hip or... | NCT04303910

Studies
An Analysis of Blood Management in Patients Having Hip or Knee Arthroplasty

NCT04303910

Sponsor

Siriraj Hospital

Status

Completed

Last Update Posted

Sep 22, 2021Actual

Enrollment

275Actual

Phase

Not provided

Conditions

Transfusion-dependent Anemia

Interventions

Not provided

Countries

Thailand

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 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

May 1, 2020Actual

Primary Completion Date

Dec 30, 2020Actual

Completion Date

Sep 20, 2021Actual

First Submitted Date

Mar 9, 2020

First Submission Date that Met QC Criteria

Mar 9, 2020

First Posted Date

Mar 11, 2020Actual

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 20, 2021

Last Update Posted Date

Sep 22, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The main objective of this study is to examine the transfusion rate and appropriateness in patients undergoing elective knee and hip replacement surgery at Siriraj Hospital

Detailed Description

The main objective of this study is to examine the transfusion rate and appropriateness in patients undergoing elective knee and hip replacement surgery at Siriraj Hospita by reviewing data from previous medical records (retrospective chart review).

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

275Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Perioperative transfusion rate	Transfusion rate in Patients Having Hip or Knee Arthroplasty in Siriraj Hospital	1 week

Secondary Outcomes

Measure	Description	Time Frame
Inappropriate transfusion rate	Perioperative inappropriate transfusion rate in Patients Having Hip or Knee Arthroplasty in Siriraj hospital	1 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients Having elective Hip or Knee Arthroplasty in Siriraj Hospital

Exclusion Criteria:

none

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

Patients Having elective Hip or Knee Arthroplasty in Siriraj Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mingkwan Wongyingsinn, MD	Siriraj Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Siriraj hospital		Bangkok		10700	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided