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

NCT ID: NCT06254352

Last Updated: 2024-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2024-11-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Upper GI Bleeding

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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scoring system

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Gamal Abd Elaal

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Ahmed Gamal Abd elaal, resident doctor

Role: CONTACT

01010995958

Ghada Mustafa Kamal, professor

Role: CONTACT

01002623401

References

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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.

Reference Type BACKGROUND
PMID: 24267496 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21980783 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22310222 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11073021 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21907980 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8675081 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37297873 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32723845 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31359521 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35820868 (View on PubMed)

Other Identifiers

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non variceal UGIT bleeding

Identifier Type: -

Identifier Source: org_study_id

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