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

Gastrointestinal Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03119987
• Other study ID #: RDWUGI
• Status: Completed
• Phase: N/A
• First received: April 14, 2017
• Last updated: March 5, 2018
• Start date: January 1, 2011
• Est. completion date: December 30, 2014

Study information

• Verified date: March 2018
• Source: Konkuk University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 30, 2014
• Est. primary completion date: December 30, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Konkuk University Medical Center

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High risk	Case of the death or re-bleeding, or blood transfusion or endoscopic therapy or operation.	30 days