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

NCT ID: NCT03119987

Last Updated: 2018-03-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-01
• Study Completion Date: 2014-12-30

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.

Conditions

Gastrointestinal Hemorrhage

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

UGIB

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

Red cell distribution widths

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Red cell distribution widths

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Konkuk University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sang O, Park

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sang O Park, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Emergency Medicine, Konkuk University School of medicine

References

Blatchford O, Murray WR, Blatchford M. A risk score to predict need for treatment for upper-gastrointestinal haemorrhage. Lancet. 2000 Oct 14;356(9238):1318-21. doi: 10.1016/S0140-6736(00)02816-6.

Reference Type: BACKGROUND

PMID: 11073021 (View on PubMed)

van Kimmenade RR, Mohammed AA, Uthamalingam S, van der Meer P, Felker GM, Januzzi JL Jr. Red blood cell distribution width and 1-year mortality in acute heart failure. Eur J Heart Fail. 2010 Feb;12(2):129-36. doi: 10.1093/eurjhf/hfp179. Epub 2009 Dec 20.

Reference Type: BACKGROUND

PMID: 20026456 (View on PubMed)

Masaoka T, Suzuki H, Hori S, Aikawa N, Hibi T. Blatchford scoring system is a useful scoring system for detecting patients with upper gastrointestinal bleeding who do not need endoscopic intervention. J Gastroenterol Hepatol. 2007 Sep;22(9):1404-8. doi: 10.1111/j.1440-1746.2006.04762.x.

Reference Type: BACKGROUND

PMID: 17716345 (View on PubMed)

Stanley AJ, Ashley D, Dalton HR, Mowat C, Gaya DR, Thompson E, Warshow U, Groome M, Cahill A, Benson G, Blatchford O, Murray W. Outpatient management of patients with low-risk upper-gastrointestinal haemorrhage: multicentre validation and prospective evaluation. Lancet. 2009 Jan 3;373(9657):42-7. doi: 10.1016/S0140-6736(08)61769-9. Epub 2008 Dec 16.

Reference Type: BACKGROUND

PMID: 19091393 (View on PubMed)

Other Identifiers

RDWUGI

Identifier Type: -

Identifier Source: org_study_id