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

NCT04825977 | Completed

• 2 other identifiers: 35/18/IEC/JMMC&RICTRI/2019/03/018127
• Study Type: observational
• Target: 348
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Gastrointestinal Bleeding

Keywords

Emergency Department, Upper GI Bleed, Risk Stratification, Mortality, Red Cell Distribution Width, AIMS65 Score, Receiver Observer Characteristic Curve

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

RISK STRATIFICATION USING AIMS65 SCORE AND RDW OTHER

Risk Statification of patients presenting with upper gastrointestinal bleeding to the emergency department using AIMS65 score and Red cell Distribution Width.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All patients presenting to ED with UGIB
• Age more than 18 years of age

You may not qualify if:

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

Sponsors & Collaborators

• Jubilee Mission Medical College and Research Institute: lead

Study Sites (1)

Jubilee Mission Medical College and Research Institute

Thrissur, Kerala, 680027, India

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Emergencies

Interventions

Erythrocyte Indices

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Siju V Abraham, MD

  Jubilee Mission Medical College

  STUDY CHAIR

• Rajeev P C, MD

  Jubilee Mission Medical College

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Resident

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 1, 2021
• Study Start: August 1, 2018
• Primary Completion: March 31, 2020
• Study Completion: October 31, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

IN (1)