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Gastrointestinal HemorrhageNGNCT00689754

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

A study testing nasogastric tube placement in people with Gastrointestinal Hemorrhage and Liver Cirrhosis, run by University of Texas Southwestern Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Gastrointestinal Hemorrhage, Liver Cirrhosis
What is being tested?
nasogastric tube placement
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
282 participants
Where
1 siteUnited States
Study dates
Jan 2008to Aug 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

Other trials in United States

About this study

Official title: The Role of Routine Placement of Nasogastric Tube in Patients With Suspected Upper Gastrointestinal Hemorrhage

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.

Being tested
nasogastric tube placement
Keywords
gastrointestinal hemorrhage, gastrointestinal intubation, endoscopy
Medical subject headings
Gastrointestinal Hemorrhage, Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nasogastric tube placementProcedure or surgery

    standard nasogastric tube placement, aspiration and lavage up to 1L of normal saline

Study groups in NCT00689754
Study groupRoleWhat they receive
NGAActive comparatorPatients will receive the standard of care to proceed with nasogastric tube placement, aspiration and lavage up to 1L of normal saline
Receives: Procedure: nasogastric tube placement
NO NGANo interventionPatient presenting with Upper GI hemorrhage going straight to endoscopy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of patients predicted accurately to have a treatable lesion

    Measured: 24h

Secondary outcomes (4)

  1. Complications of nasogastric aspiration and lavage

    Measured: 24h

  2. Relationship between time to endoscopy and upper gastrointestinal hemorrhage

    Measured: 24h

  3. Relationship of nasogastric aspirate and lavage with number of units of packed reb blood cells transfused

    Measured: 24h

  4. Complication of nasogastric tube placement and aspiration in cirrhotics

    Measured: 24h

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionAug 2011
  4. Study completionAug 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
282 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00689754
Sponsor's protocol ID
102007-022
Acronym
NG
Status last verified
Nov 2011
First submitted
2 Jun 2008
Last updated
18 Nov 2011
Results posted
No
Data monitoring committee
No

Publications

  • Luk GD, Bynum TE, Hendrix TR. Gastric aspiration in localization of gastrointestinal hemorrhage. JAMA. 1979 Feb 9;241(6):576-8.

    PubMed 310892

  • Peterson WL. Evaluation and initial management of patients with upper gastrointestinal bleeding. J Clin Gastroenterol. 1981;3(Suppl 2):79-84.

    PubMed 6976367

  • Gilbert DA, Silverstein FE, Tedesco FJ, Buenger NK, Persing J. The national ASGE survey on upper gastrointestinal bleeding. III. Endoscopy in upper gastrointestinal bleeding. Gastrointest Endosc. 1981 May;27(2):94-102. doi: 10.1016/s0016-5107(81)73157-2. No abstract available.

    PubMed 6971777

  • Cuellar RE, Gavaler JS, Alexander JA, Brouillette DE, Chien MC, Yoo YK, Rabinovitz M, Stone BG, Van Thiel DH. Gastrointestinal tract hemorrhage. The value of a nasogastric aspirate. Arch Intern Med. 1990 Jul;150(7):1381-4. doi: 10.1001/archinte.150.7.1381.

    PubMed 2196022

  • Basuk PM, Isenberg JI. Gastric lavage in patients with gastrointestinal hemorrhage. Yea or nay? Arch Intern Med. 1990 Jul;150(7):1379-80. No abstract available.

    PubMed 2369238

  • Cappell MS, Scarpa PJ, Nadler S, Miller SH. Complications of nasoenteral tubes. Intragastric tube knotting and intragastric tube breakage. J Clin Gastroenterol. 1992 Mar;14(2):144-7. doi: 10.1097/00004836-199203000-00015.

    PubMed 1556428

  • Levy H. Nasogastric and nasoenteric feeding tubes. Gastrointest Endosc Clin N Am. 1998 Jul;8(3):529-49.

    PubMed 9654567

  • Barkun A, Bardou M, Marshall JK; Nonvariceal Upper GI Bleeding Consensus Conference Group. Consensus recommendations for managing patients with nonvariceal upper gastrointestinal bleeding. Ann Intern Med. 2003 Nov 18;139(10):843-57. doi: 10.7326/0003-4819-139-10-200311180-00012.

    PubMed 14623622

  • Aljebreen AM, Fallone CA, Barkun AN. Nasogastric aspirate predicts high-risk endoscopic lesions in patients with acute upper-GI bleeding. Gastrointest Endosc. 2004 Feb;59(2):172-8. doi: 10.1016/s0016-5107(03)02543-4.

    PubMed 14745388

  • Lee SD, Kearney DJ. A randomized controlled trial of gastric lavage prior to endoscopy for acute upper gastrointestinal bleeding. J Clin Gastroenterol. 2004 Nov-Dec;38(10):861-5. doi: 10.1097/00004836-200411000-00005.

    PubMed 15492601

  • Cappell MS. Safety and efficacy of nasogastric intubation for gastrointestinal bleeding after myocardial infarction: an analysis of 125 patients at two tertiary cardiac referral hospitals. Dig Dis Sci. 2005 Nov;50(11):2063-70. doi: 10.1007/s10620-005-3008-8.

    PubMed 16240216

  • Rockey DC, Ahn C, de Melo SW Jr. Randomized pragmatic trial of nasogastric tube placement in patients with upper gastrointestinal tract bleeding. J Investig Med. 2017 Apr;65(4):759-764. doi: 10.1136/jim-2016-000375. Epub 2017 Jan 9.

    PubMed 28069629

Questions about this trial

What is this clinical trial studying?

A study testing nasogastric tube placement in people with Gastrointestinal Hemorrhage and Liver Cirrhosis, run by University of Texas Southwestern Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of patients predicted accurately to have a treatable lesion (time frame: 24h). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00689754, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2011.

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