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

Completed

• Conditions: Upper Gastrointestinal Bleeding

• Registration Number: NCT04825977
• Lead Sponsor: Jubilee Mission Medical College and Research Institute

Brief Summary

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.

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 Timeline

• Study Start: 2018-08-01
• Primary Completion: 2020-03-31
• Study Completion: 2020-10-31
• Status Verified: 2021-03
• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-03-29
• Last Update Submitted: 2021-03-29
• Study First Posted: 2021-04-01
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 348

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Jubilee Mission Medical College and Research Institute; 🇮🇳 Thrissur, Kerala, India