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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06299007
Other study ID # HYH EC 052-66-01
Secondary ID HYH EC 052-66-01
Status Completed
Phase
First received
Last updated
Start date August 1, 2023
Est. completion date December 31, 2023

Study information

Verified date March 2024
Source Hat Yai Medical Education Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 867
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Locations

Country Name City State
Thailand Hatyai Hospital Hat Yai Songkhla

Sponsors (1)

Lead Sponsor Collaborator
Hat Yai Medical Education Center

Country where clinical trial is conducted

Thailand, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary iron status measurement iron status measurement during admission among patients hospitalized for acute UGIB. During admission
Secondary Iron deficiency anemia patients with anemia who had serum ferritin < 30 µg/L and/or transferrin saturation < 16%. During admission
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