Predictive Role of Red Cell Distribution Width in Upper GI Bleeding Patients

Completed

• Conditions: Gastrointestinal Hemorrhage
• Interventions: Diagnostic Test: Red cell distribution widths

• Registration Number: NCT03119987
• Lead Sponsor: Konkuk University Medical Center

Brief Summary

Acute upper-gastrointestinal bleeding (UGIB) is a commonly encountered cause of admission in emergency department (ED). Early risk stratification allows appropriate therapy that may be helpful to advance the patient's morbidity and mortality. Investigators hypothesized that early RDW levels may have an independent, linear relationship with recurrent or massive bleeding in UGIB patients.

Detailed Description

This is a retrospective clinical study including the UGI patients in ED. All data will be collected through the electrical medical records. The major endpoints are the high risk patients and 30-days mortality which defined cases of including any of one among the death, re-bleeding, and received the intervention (such as blood transfusion, endoscopic therapy and operation).

Investigators assessed the relationship between initial RDW level and high risk patients and 30-days mortality. In addition, investigators compare the dicrimination power for predicting outcomes between the UGIB scoring system and RDW level.

Univariate and multivariate logistic regression testing and a Cox hazard regression model were used to determine the factors associated with outcome variables. In addition, investigators constructed receiver operating characteristic curves, and the areas under the curves and confidence intervals were calculated to compare the discriminatory power for outcomes.

Study Timeline

• Study Start: 2011-01-01
• Primary Completion: 2012-12-30
• Study Completion: 2014-12-30
• Study First Submitted: 2017-04-14
• Study First Submitted QC: 2017-04-18
• Study First Posted: 2017-04-19
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-05
• Last Update Posted: 2018-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Age over 18 years
• Diagnosis as Upper gastrointestinal bleeding
• Check RDW when patients visited at emergency department

Exclusion Criteria

• Paediatrics
• Follow up loss
• Data could not be acquired

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
UGIB	Red cell distribution widths	Those who was diagnosed as UGI bleeding at emergency department during the study periods. Red cell distribution widths wers checked at all patients.

Primary Outcome Measures

Name	Time	Method
High risk	30 days	Case of the death or re-bleeding, or blood transfusion or endoscopic therapy or operation.