NCT06299007

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
867

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
Last Updated

March 7, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

February 28, 2024

Last Update Submit

March 5, 2024

Conditions

Upper Gastrointestinal Bleeding

Keywords

upper gastrointestinal bleedingAnemiairon statusiron deficiency

Outcome Measures

Primary Outcomes (1)

  • iron status measurement

    iron status measurement during admission among patients hospitalized for acute UGIB.

    During admission

Secondary Outcomes (1)

  • Iron deficiency anemia

    During admission

Study Arms (1)

Group 1

Patients who were admitted due to upper gastrointestinal bleeding and had anemia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hatyai Hospital

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Related Publications (4)

  • 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.

    PMID: 31634917BACKGROUND

  • Stein J, Connor S, Virgin G, Ong DE, Pereyra L. Anemia and iron deficiency in gastrointestinal and liver conditions. World J Gastroenterol. 2016 Sep 21;22(35):7908-25. doi: 10.3748/wjg.v22.i35.7908.

    PMID: 27672287BACKGROUND

  • Kulnigg S, Stoinov S, Simanenkov V, Dudar LV, Karnafel W, Garcia LC, Sambuelli AM, D'Haens G, Gasche C. A novel intravenous iron formulation for treatment of anemia in inflammatory bowel disease: the ferric carboxymaltose (FERINJECT) randomized controlled trial. Am J Gastroenterol. 2008 May;103(5):1182-92. doi: 10.1111/j.1572-0241.2007.01744.x. Epub 2008 Mar 26.

    PMID: 18371137BACKGROUND

  • Cotter J, Baldaia C, Ferreira M, Macedo G, Pedroto I. Diagnosis and treatment of iron-deficiency anemia in gastrointestinal bleeding: A systematic review. World J Gastroenterol. 2020 Dec 7;26(45):7242-7257. doi: 10.3748/wjg.v26.i45.7242.

    PMID: 33362380BACKGROUND

MeSH Terms

Conditions

Gastrointestinal HemorrhageAnemiaIron Deficiencies

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsHematologic DiseasesHemic and Lymphatic DiseasesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hatyai Hospital

Study Record Dates

First Submitted

February 28, 2024

First Posted

March 7, 2024

Study Start

August 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

March 7, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)