Doppler Ultrasound Probe for Blood Flow Detection in Severe Upper Gastrointestinal Hemorrhage
This study is currently recruiting participants.
Verified August 2012 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 23, 2012
Last verified: August 2012
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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 |
| Contact: Barbara Serkuczewska | (310) 268-3866 | bserkucz@mednet.ucla.edu |
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: Barbara Serkuczewska (310) 268-3866 bserkucz@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 23, 2012 |
| 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 May 23, 2013