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

Upper Gastrointestinal Bleeding Clinical Trial

— RUGBE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04825977
• Other study ID #: 35/18/IEC/JMMC&RI
• Secondary ID: CTRI/2019/03/018
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: October 31, 2020

Study information

• Verified date: March 2021
• Source: Jubilee Mission Medical College and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 348
• Est. completion date: October 31, 2020
• Est. primary completion date: March 31, 2020
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Gastrointestinal Hemorrhage
• Hemorrhage
• Upper Gastrointestinal Bleeding

Intervention

Other:
• RISK STRATIFICATION USING AIMS65 SCORE AND RDW
Risk Statification of patients presenting with upper gastrointestinal bleeding to the emergency department using AIMS65 score and Red cell Distribution Width.

Locations

Country	Name	City	State
India	Jubilee Mission Medical College and Research Institute	Thrissur	Kerala

Sponsors (1)

Lead Sponsor	Collaborator
Jubilee Mission Medical College and Research Institute

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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