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Efficacy and Safety Study on Nasogastric (NG) Tube in Patients With Upper Gastrointestinal Bleed (NG)

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. Identifier: NCT00689754
Recruitment Status : Completed
First Posted : June 4, 2008
Last Update Posted : November 18, 2011
Information provided by (Responsible Party):
Silvio Melo, University of Texas Southwestern Medical Center

Brief Summary:
Upper gastrointestinal tract hemorrhage (UGIH) remains a major cause of morbidity and mortality . Nasogastric aspiration (NGA) is routinely performed in patients with UGIH to obtain important clinical data and make therapeutic decisions. But routine use of NGA remains controversial with studies reporting its usefulness and its redundant clinical information. Early esophagogastroduodenoscopy (EGD) is recommended by most gastrointestinal societies to allow for risk stratification and to perform endoscopic treatments. The results of the NGA may assist to differentiate between high-risk versus low-risk lesions. Our hypothesis is that presence of NGA can identify lesions that require endoscopic treatment and provides important clinical information to guide the treating physician. In addition, we hypothesized that the results of the NGA influence the clinical decision of the treating physician regarding the prediction of the need for endoscopic therapy. This observational randomized cross-sectional study will enroll consecutive patients with presumed UGIH and randomized them to NGA and no NGA recording its results. All patients will receive an EGD and its results will also be recorded. Subsequently, we will evaluate if the NGA is important in identifying endoscopically significant lesions. The information gained will help guide clinicians evaluating patient with UGIH.

Condition or disease Intervention/treatment Phase
Gastrointestinal Hemorrhage Liver Cirrhosis Procedure: nasogastric tube placement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Role of Routine Placement of Nasogastric Tube in Patients With Suspected Upper Gastrointestinal Hemorrhage
Study Start Date : January 2008
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: NGA
Patients will receive the standard of care to proceed with nasogastric tube placement, aspiration and lavage up to 1L of normal saline
Procedure: nasogastric tube placement
standard nasogastric tube placement, aspiration and lavage up to 1L of normal saline

No Intervention: NO NGA
Patient presenting with Upper GI hemorrhage going straight to endoscopy.

Primary Outcome Measures :
  1. The number of patients predicted accurately to have a treatable lesion [ Time Frame: 24h ]

Secondary Outcome Measures :
  1. Complications of nasogastric aspiration and lavage [ Time Frame: 24h ]
  2. Relationship between time to endoscopy and upper gastrointestinal hemorrhage [ Time Frame: 24h ]
  3. Relationship of nasogastric aspirate and lavage with number of units of packed reb blood cells transfused [ Time Frame: 24h ]
  4. Complication of nasogastric tube placement and aspiration in cirrhotics [ Time Frame: 24h ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients older then 21 years-old presenting with actual or reported: Hematemesis, Melena, or Hematemesis and Melena

Exclusion Criteria:

  • Refusal to participate
  • Severe comorbid conditions making EGD hazardous for the patient, such as myocardial infarction < 3 months with the exception if the myocardial infarction was caused by the UGIH, hemorrhagic or ischemic stroke < 3 months, decompensated congestive heart failure, severe respiratory failure unless the patient is already intubated
  • Survival expected to be less than 72h as judged by treating clinician
  • Prisoners
  • Patient with severe mental illness precluding the ability to obtain informed consent
  • Ongoing anticoagulation which can not be reversed secondary to patient safety
  • Strongly suspected gastrointestinal perforation
  • Recent endoscopy (less than 30 days)

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 identifier (NCT number): NCT00689754

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United States, Texas
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
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Principal Investigator: Silvio W Melo, MD UT Southwestern Medical Center at Dallas

Additional Information:
Publications of Results:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Silvio Melo, MD, University of Texas Southwestern Medical Center Identifier: NCT00689754    
Other Study ID Numbers: 102007-022
First Posted: June 4, 2008    Key Record Dates
Last Update Posted: November 18, 2011
Last Verified: November 2011
Keywords provided by Silvio Melo, University of Texas Southwestern Medical Center:
gastrointestinal hemorrhage
gastrointestinal intubation
Additional relevant MeSH terms:
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Liver Cirrhosis
Gastrointestinal Hemorrhage
Pathologic Processes
Liver Diseases
Digestive System Diseases
Gastrointestinal Diseases