Status:
COMPLETED
Doppler Ultrasound Probe for Blood Flow Detection in Severe Upper Gastrointestinal Hemorrhage
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
University of California, Los Angeles
Kaiser Permanente
Conditions:
UGI Bleeding
Ulcer or Variceal Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 an...
Detailed Description
Background: For patients with severe upper gastrointestinal (UGI) hemorrhage, risk stratification for rebleeding or endoscopic hemostasis has been based on visually defined endoscopic stigmata of hemo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 18 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2016
Estimated Enrollment :
235 Patients enrolled
Trial Details
Trial ID
NCT00732212
Start Date
February 18 2009
End Date
January 7 2016
Last Update
December 4 2023
Active Locations (2)
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1
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
2
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073-1003