Trial record 2 of 754 for:    Open Studies | "Hemorrhage"

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

This study is currently recruiting participants.
Verified August 2013 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00732212
First received: August 1, 2008
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

The main purpose of this study is to compare outcomes of patients with similar medical conditions, one group managed and treated by current standards (i.e. endoscopic observation(s) and the type of bleeding that have occurred) and the second managed and treated with endoscopic Doppler ultrasound probe (DUP) monitoring.


Condition Intervention
UGI Bleeding
Ulcer Hemorrhage
Stigmata of Recent Hemorrhage
Endoscopy
Randomized Controlled Trials
Device: Doppler ultrasound probe for blood flow detection

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 Department of Veterans Affairs:

Primary Outcome Measures:
  • The primary outcome is rebleeding rate up to 30 days. [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: February 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
New patients admitted to WLA VA Hospital with severe UGI hemorrhage will be randomized in RCT of doppler assisted management versus standard endoscopic/medical diagnosis, risk stratification, & treatment.
Device: Doppler ultrasound probe for blood flow detection
Used for blood flow detection

  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 -NG- tube 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, 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, we 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-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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00732212

Contacts
Contact: Dennis M Jensen, MD (310) 268-3569 dennis.jensen@va.gov

Locations
United States, California
VA Greater Los Angeles Healthcare System, West LA Recruiting
West Los Angeles, California, United States, 90073
Contact: Dennis M Jensen, MD    310-268-3569    dennis.jensen@va.gov   
Contact: Kanamas Suvanamas, BS    ((31) 478-3711 ext 43324    ksuvanamas@mednet.ucla.edu   
Principal Investigator: Dennis M. Jensen, MD         
Sponsors and Collaborators
Investigators
Principal Investigator: Dennis M. Jensen, MD VA Greater Los Angeles Healthcare System, West LA
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00732212     History of Changes
Other Study ID Numbers: CLIN-013-07F
Study First Received: August 1, 2008
Last Updated: August 9, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
UGI Bleeding
Ulcer hemorrhage
Stigmata of recent hemorrhage
Endoscopy
Randomized Controlled Trial
Non-variceal UGI hemorrhage
Variceal hemorrhage

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

ClinicalTrials.gov processed this record on April 21, 2014