Clinical Risk Scores in Prediction Outcome of Acute UGIT Bleeding in Non Cirrhotic Patients

Upper GI Bleeding Clinical Trial

Official title:

Evaluation of Clinical Risk Scores in Prediction of Outcome of Acute Upper Gastrointestinal Bleeding in Non Cirrhotic Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06254352
• Other study ID #: non variceal UGIT bleeding
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: November 30, 2024

Study information

• Verified date: January 2024
• Source: Assiut University
• Contact: Ahmed Gamal Abd elaal, resident doctor
• Phone: 01010995958
• Email: ahmed.sun1234[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To compare the ability of 4 bleeding risk scoring systems (Glasgow -Blatchford score, MAP, H3B2 and ABC scores ) in prediction of: Need of intervention, Re bleeding, Thirty-day mortality, length of hospital stay

Description:

Acute upper gastrointestinal bleeding (UGIB) is a common medical emergency which has a variceal and non-variceal etiology. The non variceal etiology has higher incidence in many countries. In Egypt, non-variceal causes ranged from 26.1% to 61.6% among UGIB cases presented to the emergency departments of different University Hospitals. Guidelines recommend risk stratification early in the management of patients with acute UGIB to help triage patients into the appropriate level of care. Many scoring systems for UGIB were developed and validated from 1990s onwards. Their primary aim was to segregate the patients into low-risk and high-risk groups. High risk patients with UGIB includes those who reach some or all of the endpoints: requirement of blood transfusion, endo-therapeutic, surgical or radiological intervention to achieve hemostasis, re bleeding and mortality. Unfortunately, no single risk score has been shown to be accurate at measuring all relevant outcomes.

The most widely used score is Glasgow Blatchford "GBS" which is a pre endoscopic score. It is useful in prediction of therapeutic intervention for bleeding. More recently, other scores have been developed as ABC score which showed good performance for predicting mortality. MAP score highly predicted therapeutic intervention and mortality. H3B2 score predicted the need of urgent hemostasis.

Limited data are available on the validity of the new scoring systems in predicting the outcome of Egyptian non-cirrhotic patients with acute UGIB. Therefore, The investigators will conduct our study to shed some light on this topic.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult non cirrhotic patients

• patients more than 18 years old

• Hematemesis or coffee grounds vomiting.

• Melena with or without hematemesis.

• Blood in nasogastric tube in emergency unit.

Exclusion Criteria:

• Patients younger than 18 years old.

• Patients known to be cirrhotic.

• Patients presented with GIT bleeding but refuse to be examined by GIT endoscopy.

Related Conditions & MeSH terms

• Hemorrhage
• Upper GI Bleeding

Intervention

Diagnostic Test:
• scoring system
Clinical Risk Scores in Prediction of Outcome of Acute Upper Gastrointestinal Bleeding in Non Cirrhotic Patients.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (10)

Blatchford O, Murray WR, Blatchford M. A risk score to predict need for treatment for upper-gastrointestinal haemorrhage. Lancet. 2000 Oct 14;356(9238):1318-21. doi: 10.1016/S0140-6736(00)02816-6. — View Citation

Elwakil R, Reda MA, Abdelhakam SM, Ghoraba DM, Ibrahim WA. Causes and outcome of upper gastrointestinal bleeding in Emergency Endoscopy Unit of Ain Shams University Hospital. J Egypt Soc Parasitol. 2011 Aug;41(2):455-67. — View Citation

Feinman M, Haut ER. Upper gastrointestinal bleeding. Surg Clin North Am. 2014 Feb;94(1):43-53. doi: 10.1016/j.suc.2013.10.004. — View Citation

Laine L, Jensen DM. Management of patients with ulcer bleeding. Am J Gastroenterol. 2012 Mar;107(3):345-60; quiz 361. doi: 10.1038/ajg.2011.480. Epub 2012 Feb 7. — View Citation

Laursen SB, Oakland K, Laine L, Bieber V, Marmo R, Redondo-Cerezo E, Dalton HR, Ngu J, Schultz M, Soncini M, Gralnek I, Jairath V, Murray IA, Stanley AJ. ABC score: a new risk score that accurately predicts mortality in acute upper and lower gastrointestinal bleeding: an international multicentre study. Gut. 2021 Apr;70(4):707-716. doi: 10.1136/gutjnl-2019-320002. Epub 2020 Jul 28. — View Citation

Orpen-Palmer J, Stanley AJ. A Review of Risk Scores within Upper Gastrointestinal Bleeding. J Clin Med. 2023 May 26;12(11):3678. doi: 10.3390/jcm12113678. — View Citation

Redondo-Cerezo E, Vadillo-Calles F, Stanley AJ, Laursen S, Laine L, Dalton HR, Ngu JH, Schultz M, Jimenez-Rosales R. MAP(ASH): A new scoring system for the prediction of intervention and mortality in upper gastrointestinal bleeding. J Gastroenterol Hepatol. 2020 Jan;35(1):82-89. doi: 10.1111/jgh.14811. Epub 2019 Aug 19. — View Citation

Rockall TA, Logan RF, Devlin HB, Northfield TC. Risk assessment after acute upper gastrointestinal haemorrhage. Gut. 1996 Mar;38(3):316-21. doi: 10.1136/gut.38.3.316. — View Citation

Saltzman JR, Tabak YP, Hyett BH, Sun X, Travis AC, Johannes RS. A simple risk score accurately predicts in-hospital mortality, length of stay, and cost in acute upper GI bleeding. Gastrointest Endosc. 2011 Dec;74(6):1215-24. doi: 10.1016/j.gie.2011.06.024. Epub 2011 Sep 10. — View Citation

Sasaki Y, Abe T, Kawamura N, Keitoku T, Shibata I, Ohno S, Ono K, Makishima M. Prediction of the need for emergency endoscopic treatment for upper gastrointestinal bleeding and new score model: a retrospective study. BMC Gastroenterol. 2022 Jul 11;22(1):337. doi: 10.1186/s12876-022-02413-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation between Glasgow -Blatchford score, MAP score.	correlation between Glasgow -Blatchford score, MAP score regarding to Need of intervention, Re bleeding, Thirty-day mortality, length of hospital stay.	Baseline
Primary	correlation between Glasgow -Blatchford score, H3B2 score.	correlation between Glasgow -Blatchford score, H3B2 score regarding to Need of intervention, Re bleeding, Thirty-day mortality, length of hospital stay.	Baseline
Primary	correlation between Glasgow -Blatchford score, ABC score.	correlation between Glasgow -Blatchford score, ABC score regarding to Need of intervention, Re bleeding, Thirty-day mortality, length of hospital stay.	Baseline
Primary	correlation between MAP score, H3B2 score.	correlation between MAP score, H3B2 score regarding to Need of intervention, Re bleeding, Thirty-day mortality, length of hospital stay .	Baseline
Primary	correlation between MAP score, ABC score.	correlation between MAP score, ABC score regarding to Need of intervention, Re bleeding, Thirty-day mortality, length of hospital stay.	Baseline
Primary	correlation between H3B2 score, ABC score.	correlation between H3B2 score, ABC score regarding to Need of intervention, Re bleeding, Thirty-day mortality, length of hospital stay.	Baseline