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

This study has been completed.
Sponsor:
Collaborator:
UCLA Ronald Reagan Medical Center
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00732212
First received: August 1, 2008
Last updated: January 28, 2016
Last verified: January 2016
  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 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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:
  • The primary outcome is index lesion rebleeding rate up to 30 days in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to Doppler assisted vs. standard visually guided hemostasis [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rates of surgery up to 30 days after randomization [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    GI surgery rate for control of active bleeding or rebleeding - up to 30 days after randomization.

  • Rate of complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Rates for each treatment group will be determined and compared for General medical complications (pneumonia, infection, MI, stroke) & GI procedure related (perforation, aspiration) up to 30 days.

  • Death [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Death up to 30 days from a co-morbid condition, bleeding, or another cause

  • Units of Red blood cells transfused for rebleeding after randomization [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    RBC units of transfusion post-randomization will be quantitated & compared for the Doppler vs. standard treatment groups


Other Outcome Measures:
  • Hospital days after randomization [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Comparisons of days spent in the ICU and hospital will be quantitated & compared for Doppler vs. Standard treatment groups.


Enrollment: 236
Study Start Date: February 2009
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Doppler endoscopic probe assisted 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 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 also 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00732212     History of Changes
Other Study ID Numbers: CLIN-013-07F 
Study First Received: August 1, 2008
Last Updated: January 28, 2016
Health Authority: United States: Federal Government

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:
Gastrointestinal Hemorrhage
Hemorrhage
Digestive System Diseases
Gastrointestinal Diseases
Pathologic Processes
Hemostatics
Coagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on February 11, 2016