Awareness of Iron Status Evaluation in UGIB | NCT06299007

Studies
Awareness of Iron Status Evaluation in UGIB

NCT06299007

Sponsor

Hat Yai Medical Education Center

Status

Completed

Last Update Posted

Mar 7, 2024Actual

Enrollment

867Actual

Phase

Not provided

Conditions

Upper Gastrointestinal Bleeding

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

ID	Type	Description	Link
HYH EC 052-66-01	Other Grant/Funding Number	Hatyai Hospital Education Center

Status Module

Record Verification Date

Mar 2024

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

Aug 1, 2023Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

Feb 28, 2024

First Submission Date that Met QC Criteria

Mar 5, 2024

First Posted Date

Mar 7, 2024Actual

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

Mar 5, 2024

Last Update Posted Date

Mar 7, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Arunchai Chang, Hatyai Hospital, Hat Yai Medical Education CenterPrincipal Investigator

Lead Sponsor

Hat Yai Medical Education CenterOTHER

Collaborators

Not provided

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

BACKGROUND: Data on the awareness of the need to evaluate iron status and IDA prevalence in acute UGIB are limited.

OBJECTIVES: This study aimed to investigate the rate of evaluation of iron status and prevalence of iron deficiency anemia (IDA) and the associated factors in patients with anemia hospitalized for acute upper gastrointestinal bleeding (UGIB).

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

867Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Patients who were admitted due to upper gastrointestinal bleeding and had anemia

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
iron status measurement	iron status measurement during admission among patients hospitalized for acute UGIB.	During admission

Secondary Outcomes

Measure	Description	Time Frame
Iron deficiency anemia	patients with anemia who had serum ferritin < 30 μg/L and/or transferrin saturation < 16%.	During admission

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients > 18 years of age who were admitted because of acute UGIB and were diagnosed with anemia from UGIB during hospitalization.

Exclusion Criteria:

patients who had previously undergone endoscopy at another institution before admission
patients who had a definite cause of UGIB that was inconclusive
incomplete data for analysis.

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 who were admitted because of acute UGIB at Hatyai Hospital between January 2016 and December 2019.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hatyai Hospital		Hat Yai	Changwat Songkhla	90110	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31634917	Background	Barkun AN, Almadi M, Kuipers EJ, Laine L, Sung J, Tse F, Leontiadis GI, Abraham NS, Calvet X, Chan FKL, Douketis J, Enns R, Gralnek IM, Jairath V, Jensen D, Lau J, Lip GYH, Loffroy R, Maluf-Filho F, Meltzer AC, Reddy N, Saltzman JR, Marshall JK, Bardou M. Management of Nonvariceal Upper Gastrointestinal Bleeding: Guideline Recommendations From the International Consensus Group. Ann Intern Med. 2019 Dec 3;171(11):805-822. doi: 10.7326/M19-1795. Epub 2019 Oct 22.
27672287

ID	Term
D006471	Gastrointestinal Hemorrhage
D000740	Anemia
D000090463	Iron Deficiencies

ID	Term
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D006470	Hemorrhage
D010335	Pathologic Processes