Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03119987
Recruitment Status : Completed
First Posted : April 19, 2017
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Sang O, Park, 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.

Condition or disease Intervention/treatment
Gastrointestinal Hemorrhage Diagnostic Test: Red cell distribution widths

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Efficacy of Red Cell Distribution Width as a Predictor of High Risk and Early Mortality in Upper Gastro-intestinal Bleeding
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : December 30, 2012
Actual Study Completion Date : December 30, 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
UGIB
Those who was diagnosed as UGI bleeding at emergency department during the study periods. Red cell distribution widths wers checked at all patients.
Diagnostic Test: Red cell distribution widths
Measured value of Red cell distribution widths in initial laboratory result of blood cell counts at emergency department




Primary Outcome Measures :
  1. High risk [ Time Frame: 30 days ]
    Case of the death or re-bleeding, or blood transfusion or endoscopic therapy or operation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients who visited to emergency department due to Upper gastrointestinal bleeding
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119987


Sponsors and Collaborators
Konkuk University Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Sang O Park, MD Department of Emergency Medicine, Konkuk University School of medicine
Publications:
Layout table for additonal information
Responsible Party: Sang O, Park, Associate Professor, Konkuk University Medical Center
ClinicalTrials.gov Identifier: NCT03119987    
Other Study ID Numbers: RDWUGI
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sang O, Park, Konkuk University Medical Center:
Red cell Distribution Width
Risk
Mortality
Hemorrhage
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases