Clinical trial NCT04825977: Risk Stratification of Patients Presenting With Upper Gastrointestinal Bleeding to the Emergency Department Using AIMS65 Score and Red Cell Distribution Width
Official title: Risk Stratification of Patients Presenting With Upper Gastrointestinal Bleeding to the Emergency Department Using AIMS65 Score and Red Cell Distribution Width
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Upper Gastrointestinal Bleeding
Keywords: Emergency Department, Upper GI Bleed, Risk Stratification, Mortality, Red Cell Distribution Width, AIMS65 Score, Receiver Observer Characteristic Curve
Lead sponsor: Jubilee Mission Medical College and Research Institute
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 348
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Thrissur
country: India
facility: Jubilee Mission Medical College and Research Institute
state: Kerala
Study officials:
affiliation: Jubilee Mission Medical College
name: Siju V Abraham, MD
role: STUDY_CHAIR
affiliation: Jubilee Mission Medical College
name: Rajeev P C, MD
role: STUDY_DIRECTOR
References: