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Doppler Ultrasound Probe for Blood Flow Detection in Severe Upper Gastrointestinal Hemorrhage

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00732212
First Posted: August 11, 2008
Last Update Posted: July 13, 2017
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.
Collaborator:
UCLA Ronald Reagan Medical Center
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
The main purposes of this study are to compare clinical outcomes of two groups of patients with similar medical conditions (one with non-variceal upper gastrointestinal (UGI) lesions such as ulcers and another group with varices or portal hypertensive lesions) who are treated either with current standard visually guided endoscopic treatment according to stigmata of hemorrhage or with endoscopic Doppler endoscopic ultrasound probe (DEP) monitoring of blood flow in the lesion.

Condition Intervention
UGI Bleeding Ulcer or Variceal Hemorrhage Stigmata of Recent Hemorrhage Endoscopy Randomized Controlled Trials Device: Doppler endoscopic ultrasound probe for blood flow detection Other: Standard endoscopic hemostasis

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Doppler Ultrasound Probe for Blood Flow Detection in Severe UGI Bleed

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 30 Day Rebleeding Rate [ Time Frame: 30 days ]
    The primary outcome is index lesion rebleeding rate up to 30 days in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.


Secondary Outcome Measures:
  • Rates of Surgery up to 30 Days After Randomization [ Time Frame: 30 days ]
    GI surgery rate for control of active bleeding or rebleeding - up to 30 days after randomization in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.

  • Rate of Complications [ Time Frame: 30 days ]
    Rates for each treatment group will be determined and compared for General medical complications (pneumonia, infection, myocardial infarction, stroke) & GI procedure related (perforation, aspiration) up to 30 days in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.

  • Death [ Time Frame: 30 days ]
    Death up to 30 days from a co-morbid condition, bleeding, or another cause in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.

  • Units of Red Blood Cells (RBC) Transfused for Rebleeding After Randomization [ Time Frame: 30 days ]
    RBC units of transfusion post-randomization will be quantitated & compared in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.


Other Outcome Measures:
  • Hospital Days After Randomization [ Time Frame: 30 days ]
    Comparisons of days spent in the ICU and hospital will be quantitated & compared in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.


Enrollment: 235
Actual Study Start Date: February 18, 2009
Study Completion Date: January 7, 2016
Primary Completion Date: January 7, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Doppler endoscopic probe hemostasis
In addition to stigmata of hemorrhage and visual cues, Doppler endoscopic probe will be used for detection of blood flow before and after standard endoscopic hemostasis. If residual blood flow in the lesion is found after standard treatment, further endoscopic treatment will be applied as deemed safe by the investigator-endoscopist.
Device: Doppler endoscopic ultrasound probe for blood flow detection
Used for blood flow detection
Active Comparator: Standard Endoscopic Hemostasis
Standard, visually guided endoscopic hemostasis based on visual cues of stigmata of hemorrhage and endoscopic control of bleeding or treatment of the stigmata according to current guidelines
Other: Standard endoscopic hemostasis
Per current treatment guidelines for non-variceal UGI lesions - based upon stigmata of hemorrhage & visual cues for risk stratification and completion of endoscopic treatment.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have evidence of severe UGI bleeding by laboratory tests (Hgb less than or equal to 9 gms; with red blood cell (RBC) transfusions; or documented decrease in Hgb of greater than or equal to 2 gms relative to baseline) and by clinical parameters (melena; hematemesis or hematochezia; nasogastric tube (NG) evidence of UGI bleeding- fresh blood, clots, or old blood).
  • The following non-variceal UGI lesions will be included if stigmata of hemorrhage are found on emergency endoscopy (active arterial bleeding, oozing, non-bleeding visible vessel (NBVV), adherent clot, or flat spot or a combination of these) for peptic ulcers (gastric, duodenal, esophageal, or anastomatic), Mallory-Weiss (MW) tears without portal hypertension (PHTN), or Dieulafoy's lesions.
  • For other types of severe UGI bleeding related to PHTN, the investigators will include patients with esophageal or gastric varices (with or without stigmata, if no other UGI lesion is the source of the bleed); post-rubber band ligation (RBL) ulcers, and MW tears associated with PHTN and having some stigmata of recent hemorrhage.
  • Life expectancy of at least 60 days based on lack of very severe or terminal comorbidity, as judged by the generalists or specialists caring for the patient.
  • Written informed consent by patient or surrogate.

Exclusion Criteria:

  • Patients who are uncooperative, unable to give written informed consent, who cannot return for 30 day follow-up, or refuse informed consent.
  • Patients with UGI known malignancies or malignant appearing ulcers; diffuse bleeding from mucosal lesions or esophagitis; infectious UGI lesions; or other bleeding lesions (polyps, post-endoscopic mucosal resection (EMR), or post-sphincterotomy).
  • End-stage, very severe, recurrent or ongoing co-morbid illness, e.g. severe liver, renal, cardiac, respiratory failure; peritonitis; or sepsis that preclude emergency procedures or clinical follow-up and limit survival.
  • Persistent shock or hypotension (e.g. systolic blood pressure less than or equal to 99 mm mercury) that is unresponsive to less than or equal to 6 units of packed red blood cell (RBC) transfusions or requires continuous intravenous infusions of vasoactive drugs for blood pressure elevation.
  • Severe coagulopathy unresponsive to blood transfusions e.g. international normalized ratio (INR) > 2.0, platelet count < 20,000, activated partial thromboplastin time (APTT) greater than 2.0 x normal, or bleeding time > 10 minutes.
  • Contraindication to urgent endoscopy or follow-up procedures.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00732212


Locations
United States, California
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
VA Office of Research and Development
UCLA Ronald Reagan Medical Center
Investigators
Principal Investigator: Dennis M. Jensen, MD VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00732212     History of Changes
Other Study ID Numbers: CLIN-013-07F
First Submitted: August 1, 2008
First Posted: August 11, 2008
Results First Submitted: February 24, 2017
Results First Posted: April 11, 2017
Last Update Posted: July 13, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by VA Office of Research and Development:
UGI Bleeding
Ulcer or variceal hemorrhage
Stigmata of recent hemorrhage
Endoscopy
Randomized Controlled Trial
Non-variceal UGI hemorrhage
Variceal hemorrhage

Additional relevant MeSH terms:
Hemorrhage
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Hemostatics
Coagulants


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