NCT03119987

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2014

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 19, 2017

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

2 years

First QC Date

April 14, 2017

Last Update Submit

March 5, 2018

Conditions

Keywords

Red cell Distribution WidthRiskMortalityHemorrhage

Outcome Measures

Primary Outcomes (1)

  • High risk

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

    30 days

Study Arms (1)

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

Interventions

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

UGIB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients who visited to emergency department due to Upper gastrointestinal bleeding

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 11073021BACKGROUND
  • 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.

    PMID: 20026456BACKGROUND
  • 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.

    PMID: 17716345BACKGROUND
  • 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.

    PMID: 19091393BACKGROUND

MeSH Terms

Conditions

Gastrointestinal HemorrhageHemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sang O Park, MD

    Department of Emergency Medicine, Konkuk University School of medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 14, 2017

First Posted

April 19, 2017

Study Start

January 1, 2011

Primary Completion

December 30, 2012

Study Completion

December 30, 2014

Last Updated

March 7, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share