Risk Stratification of Patients Presenting With Upper Gastrointestinal Bleeding to the Emergency Department Using AIMS65 Score and Red Cell Distribution Width (RUGBE)

The rationale of this study in UGIB patients is to assess whether the prediction of mortality and morbidity using AIMS65 score improves when used in combination with RDW in the emergency department setting.

Study Overview

• Status: Completed
• Conditions: Upper Gastrointestinal Bleeding
• Intervention / Treatment: Other: RISK STRATIFICATION USING AIMS65 SCORE AND RDW

Detailed Description

UGIB is a ticking time-bomb and emergency physicians are challenged to accurately assess risk, and aggressively manage patients with gastrointestinal bleeding within the stipulated time in the confines of emergency department. If not managed properly, it is associated with high mortality.

Various clinical prediction scores help in risk stratifying such patients. Among the scores, AIMS65 score is the easy to use score and has good mortality predictive accuracy. RDW, once thought as marker of chronic blood loss has recently been identified as a good prognostic indicator as well as good predictor of mortality in conditions where there is acute blood loss.

Both AIMS65 score and RDW value have been used separately as a predictor of morbidity and mortality in patients with UGIB. But there are not much studies so far evaluating their combined role as marker of predicting mortality as well as high risk among UGIB patients. Hence there is a need for a study to know the predictive value of combination of AIMS6S score and RDW in patients presenting to ED with symptoms of UGIB not been much studies comparing the relationship between RDW and upper GI bleed.

The rationale of this study in UGIB patients is to assess whether the prediction of mortality and morbidity using AIMS65 score improves when used in combination with RDW in the emergency department setting.

• Study Type: Observational
• Enrollment (Actual): 348

Contacts and Locations

Study Locations

• India
  • Kerala
    • Thrissur, Kerala, India, 680027
      • Jubilee Mission Medical College and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adult (>18 years of age) patients presenting with UGIB to the ED of Jubilee Mission Medical College and Research Institute during the 18 months' time period were included in the study. The diagnosis of UGIB was based on patients' presentations, including coffee ground vomitus, hematemesis, melena, and blood in nasogastric aspirate. These patients were considered eligible for the study.

Description

Inclusion Criteria:

1. All patients presenting to ED with UGIB
2. Age more than 18 years of age

Exclusion Criteria:

1. Patients not consenting to study
2. Patients with known hematological disorders
3. Patients in which endoscopy or blood transfusion is done outside
4. Patients in which RDW value and laboratory parameters required for AIMS65 score are not available.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
predictive accuracy of addition of RDW to AIMS65 SCORE in determining the 30-day mortality of patients presenting to the ED with symptoms of UGIB	30 days

Collaborators and Investigators

• Sponsor: Jubilee Mission Medical College and Research Institute
• Investigators: Study Chair: Siju V Abraham, MD, Jubilee Mission Medical College; Study Director: Rajeev P C, MD, Jubilee Mission Medical College

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): October 31, 2020

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Emergency Department, Upper GI Bleed, Risk Stratification, Mortality, Red Cell Distribution Width, AIMS65 Score, Receiver Observer Characteristic Curve
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Emergencies; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: 35/18/IEC/JMMC&RI; CTRI/2019/03/018127 (Registry Identifier: Clinical Trials Registry - India)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No