Upper GI BleedingNCT06254352
Clinical Risk Scores in Prediction Outcome of Acute UGIT Bleeding in Non Cirrhotic Patients
An observational study of Upper GI Bleeding, run by Assiut University.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper GI Bleeding
- What is being tested?
- scoring system
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 30 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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 :
Who may be able to join
- 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.
Who cannot join
- Patients younger than 18 years old.
- Patients known to be cirrhotic.
- Patients presented with GIT bleeding but refuse to be examined by GIT endoscopy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Clinical Risk Scores in Prediction of Outcome of Acute Upper Gastrointestinal Bleeding in Non Cirrhotic Patients
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
Read the detailed 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.
- Conditions
- Upper GI Bleeding
- Being tested
- scoring system
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scoring systemDiagnostic test
Clinical Risk Scores in Prediction of Outcome of Acute Upper Gastrointestinal Bleeding in Non Cirrhotic Patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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 .
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Upper GI BleedingStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Gamal Abd Elaal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254352
- Sponsor's protocol ID
- non variceal UGIT bleeding
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24267496Elwakil 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.
PubMed 21980783Laine 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.
PubMed 22310222Blatchford 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.
PubMed 11073021Saltzman 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.
PubMed 21907980Rockall 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.
PubMed 8675081Orpen-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.
PubMed 37297873Laursen 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.
PubMed 32723845Redondo-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.
PubMed 31359521Sasaki 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.
PubMed 35820868
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Risk Scores in Prediction of Outcome of Acute Upper Gastrointestinal Bleeding in Non Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT06254352
- Acronym / sponsor ID
- non variceal UGIT bleeding
- Conditions
- Upper GI Bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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 :
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients younger than 18 years old.
- Patients known to be cirrhotic.
- Patients presented with GIT bleeding but refuse to be examined by GIT endoscopy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| scoring systemClinical Risk Scores in Prediction of Outcome of Acute Upper Gastrointestinal Bleeding in Non Cirrhotic Patients. | Diagnostic test | – |
Primary outcome
correlation between Glasgow -Blatchford score, MAP score.
Time frame: Baseline
correlation between Glasgow -Blatchford score, MAP score regarding to Need of intervention, Re bleeding, Thirty-day mortality, length of hospital stay.
correlation between Glasgow -Blatchford score, H3B2 score.
Time frame: Baseline
correlation between Glasgow -Blatchford score, H3B2 score regarding to Need of intervention, Re bleeding, Thirty-day mortality, length of hospital stay.
correlation between Glasgow -Blatchford score, ABC score.
Time frame: Baseline
correlation between Glasgow -Blatchford score, ABC score regarding to Need of intervention, Re bleeding, Thirty-day mortality, length of hospital stay.
correlation between MAP score, H3B2 score.
Time frame: Baseline
correlation between MAP score, H3B2 score regarding to Need of intervention, Re bleeding, Thirty-day mortality, length of hospital stay .
correlation between MAP score, ABC score.
Time frame: Baseline
correlation between MAP score, ABC score regarding to Need of intervention, Re bleeding, Thirty-day mortality, length of hospital stay.
correlation between H3B2 score, ABC score.
Time frame: Baseline
correlation between H3B2 score, ABC score regarding to Need of intervention, Re bleeding, Thirty-day mortality, length of hospital stay.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Background: PubMed 24267496Feinman M, Haut ER. Upper gastrointestinal bleeding. Surg Clin North Am. 2014 Feb;94(1):43-53. doi: 10.1016/j.suc.2013.10.004.
- Background: PubMed 21980783Elwakil 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.
- Background: PubMed 22310222Laine 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.
- Background: PubMed 11073021Blatchford 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.
- Background: PubMed 21907980Saltzman 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.
- Background: PubMed 8675081Rockall 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.
- Background: PubMed 37297873Orpen-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.
- Background: PubMed 32723845Laursen 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.
- Background: PubMed 31359521Redondo-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.
- Background: PubMed 35820868Sasaki 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper GI Bleeding, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Gamal Abd elaal, resident doctor (01010995958, ahmed.sun1234@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between Glasgow -Blatchford score, MAP score. (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06254352, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.