NCT06254352

Brief 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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

January 15, 2024

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 12, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

February 12, 2024

Status Verified

January 1, 2024

Enrollment Period

9 months

First QC Date

January 15, 2024

Last Update Submit

February 4, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Interventions

scoring systemDIAGNOSTIC_TEST

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

Eligibility Criteria

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

All patients within the current study will be subjected to: I-Complete medical history. II-Through clinical examination. III-Laboratory investigations including Complete blood count (CBC) Liver profile (serum bilirubin, serum albumin, PT and INR) Blood urea and creatinine IV-Abdominal Ultrasonography : VI-Risk scoring systems : At the time of admission, each of following 4 scores will be calculated and recorded (Glasgow Blatchford score, MAP score, H3B2 score and ABC score to validate outcome in the studied patients The Glasgow-Blatchford score "GBS" (6) MAP score, (11) The ABC score: (10) H3B2 score (12) V-Upper GIT endoscopy :

You may qualify if:

  • 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.

You may not qualify if:

  • Patients younger than 18 years old.
  • Patients known to be cirrhotic.
  • Patients presented with GIT bleeding but refuse to be examined by GIT endoscopy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • 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.

    PMID: 24267496BACKGROUND
  • 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.

    PMID: 21980783BACKGROUND
  • 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.

    PMID: 22310222BACKGROUND
  • 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.

    PMID: 11073021BACKGROUND
  • 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.

    PMID: 21907980BACKGROUND
  • 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.

    PMID: 8675081BACKGROUND
  • 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.

    PMID: 37297873BACKGROUND
  • 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.

    PMID: 32723845BACKGROUND
  • 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.

    PMID: 31359521BACKGROUND
  • 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.

    PMID: 35820868BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Ahmed Gamal Abd elaal, resident doctor

CONTACT

Ghada Mustafa Kamal, professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 15, 2024

First Posted

February 12, 2024

Study Start

March 1, 2024

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

February 12, 2024

Record last verified: 2024-01