Evaluation of Prognostic Scores in Patients With Upper Gastrointestinal Bleeding and Cancer

NCT02508883 | Completed DMC

• 1 other identifier: NP621/14
• Study Type: observational
• Target: 243
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective and observational study to evaluate oncologic patients that presented upper gastrointestinal bleeding with the use of some prognostic scores.

Conditions

Upper Gastrointestinal Bleeding

Keywords

Cancer; hemorrhage; endoscopy; gastrointestinal hemorrhage

Outcome Measures

Primary Outcomes (5)

• blood transfusions administered

  The need and amount of blood transfusions administered

  30 days

• Endoscopic therapy

  Hemostatic endoscopic therapy will be performed if there are findings of active or recent bleeding, under conscious or deep sedation after hemodynamic stabilization and oral fasting

  30 days

• Surgery

  need for surgery to control tumour bleeding

  participants will be followed for the duration of hospital stay, an expected average of 30 days

• rebleeding

  episodes of rebleeding

  30 days

• mortality

  mortality

  30 days

Secondary Outcomes (1)

• Finding the cut-off value of highest sensitivity and specificity of Rockall, Glasgow-Blatchford and AIMS65 scores employing the receiver operating curve (ROC).

  1 year

Study Arms (1)

Upper gastrointestinal bleeding

patients with cancer who presented or were admitted in the emergency room, wards or intensive care units of the Cancer Institute of São Paulo (ICESP), with a recent episode of upper gastrointestinal bleeding.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients referred to the Endoscopy Unit of ICESP because of upper gastrointestinal bleeding will be included consecutively, according to the selection criteria mentioned below. The analysis of our recent data base allows us to estimate an accrual of about 300 patients at the end of 1 year of study.

You may qualify if:

• Confirmed diagnosis of malignant neoplasm of any site, either located inside or outside of GI tract;
• Current evidence of bleeding in the last 48 hours, either by presenting hematemesis and/or melena, with or without hemodynamic instability. Patients with hematochezia or bright red blood per rectum due to a site of bleeding in upper GI tract will also be included.

You may not qualify if:

• Age \< 18 years-old;
• Suspicion or confirmation of pregnancy.
• Patients with no evidence of malignant neoplasm after curative surgery or oncologic therapy.

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (1)

Cancer Institute of São Paulo

São Paulo, São Paulo, 01246-000, Brazil

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Neoplasms; Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fauze Maluf-Filho, MD, PHD

  Cancer Institute of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: July 27, 2015
• Study Start: April 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 6, 2016

Record last verified: 2016-10

Locations

BR (1)