- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05773339
Prognostic Value of AIMS65 Score to Predict Outcome in Patients With Acute Upper Gastrointestinal Bleeding
Study Overview
Status
Intervention / Treatment
Detailed Description
Gastrointestinal (GI) bleeding is one of the most important disease presentations in the emergency department. The course of the disease ranges from a self-limiting process to a life-threatening condition that requires emergency intervention. Evaluation of severity and the need for endoscopic hemostasis are matters of immediate decision. several prognostic scoring systems have been used to predict outcomes of upper GI bleeding ,such as the Rockall score, Glasgow-Blatchford score (GBS), and the AIMS65 score, among which AIMS65 is relatively easy to remember and simple to calculate by using parameters routinely available in the ED and importantly does not require endoscopic variables for calculation..
The AIMS65 score consists of five factors:
(i)albumin (1 point for value less than 3.0 g/dL (30 g/L)). (ii)INR (1 point for value greater than 1.5) . (iii)altered mental status (1 point given if Glasgow coma score was less than 14 or if disorientation, lethargy, stupor, or coma was seen) (iv)systolic blood pressure (1 point for value less than 90 mmHg). (v)age (1 point for value greater than 65 years). AIMS65 score >1: high risk patients. AIMS65 score >2: consider ICU management and an urgent endoscopy following adequate volume resuscitation, while AIMS65 score of 0 can be considered for outpatient management.
AIMS65 score is a simple non-endoscopic risk score that can be applied in patients of acute upper gastrointestinal bleeding to risk stratify and to predict in-patient mortality, the need for blood transfusion, endoscopic therapy or ICU admission.
In a comparative study of AIMS65 score and GBS ,they found that the AIMS65 score was superior in predicting inpatient mortality from UGIB, while the GBS was superior for predicting the need for blood transfusion. Both scores were similar in predicting the composite clinical endpoint .
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: nessma M abbass, resident
- Phone Number: 01009692981
- Email: nesmamahmoud@med.sohag.edu.eg
Study Contact Backup
- Name: Ali T Ali, professor
- Phone Number: 01005871047
Study Locations
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Sohag, Egypt, Sohag
- Recruiting
- Sohag university Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Patients above 18 years of age.
- Patients with acute UGIB presenting within 24 hours of hemorrhage onset.
- Endoscopic evaluation done after hospital admission.
Description
Inclusion Criteria:
o Patients above 18 years of age.
- Patients with acute UGIB presenting within 24 hours of hemorrhage onset.
- Endoscopic evaluation done after hospital admission.
Exclusion Criteria:
o Patients denying for consent.
- Patients with late presentation (>24 hours) after UGIB onset.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
to evaluate the prognostic value of AIMS65 score in patients with upper gastrointestinal tract bleeding admitted to Sohag University Hospital.
Time Frame: 6 months
|
blood transfusion endoscopic therapy ICU admission Need of surgery, incidence of rebleeding duration of hospital and ICU stay.
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6 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Bryant RV, Kuo P, Williamson K, Yam C, Schoeman MN, Holloway RH, Nguyen NQ. Performance of the Glasgow-Blatchford score in predicting clinical outcomes and intervention in hospitalized patients with upper GI bleeding. Gastrointest Endosc. 2013 Oct;78(4):576-83. doi: 10.1016/j.gie.2013.05.003. Epub 2013 Jun 18.
- 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.
- Thandassery RB, Sharma M, John AK, Al-Ejji KM, Wani H, Sultan K, Al-Mohannadi M, Yakoob R, Derbala M, Al-Dweik N, Butt MT, Al-Kaabi SR. Clinical Application of AIMS65 Scores to Predict Outcomes in Patients with Upper Gastrointestinal Hemorrhage. Clin Endosc. 2015 Sep;48(5):380-4. doi: 10.5946/ce.2015.48.5.380. Epub 2015 Sep 30.
- Stanley AJ, Laine L, Dalton HR, Ngu JH, Schultz M, Abazi R, Zakko L, Thornton S, Wilkinson K, Khor CJ, Murray IA, Laursen SB; International Gastrointestinal Bleeding Consortium. Comparison of risk scoring systems for patients presenting with upper gastrointestinal bleeding: international multicentre prospective study. BMJ. 2017 Jan 4;356:i6432. doi: 10.1136/bmj.i6432.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-23-02-07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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