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OpenTrials
Completed

NCT Number: NCT03119987

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Red cell distribution widths

Diagnostic Test

Measured value of Red cell distribution widths in initial laboratory result of blood cell counts at emergency department

Primary outcomes

  1. High risk

    Time frame: 30 days

    Case of the death or re-bleeding, or blood transfusion or endoscopic therapy or operation.

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Registry information

Official study title

Efficacy of Red Cell Distribution Width as a Predictor of High Risk and Early Mortality in Upper Gastro-intestinal Bleeding

Important dates

Study start
2011
Primary completion
2012
Study completion
2014
First posted
Apr 19, 2017
Registry last updated
Mar 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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