Standard Endoscopic Hemostasis Versus OVESCO Severe Non-variceal UGI Hemorrhage (NCT03065465) | Clinical Trial Compass
UnknownNot Applicable
Standard Endoscopic Hemostasis Versus OVESCO Severe Non-variceal UGI Hemorrhage
United States65 participantsStarted 2015-11-15
Plain-language summary
The primary specific aim is to perform a randomized controlled trial (RCT) to compare 30 day rebleed rates and other clinical outcomes of patients with severe, non-variceal upper GI hemorrhage (NVUGIH) - ulcers and Dieulafoy's lesions who are randomized as initial treatment with the new large over-the-scope-clip device for endoscopic hemostasis versus standard endoscopic hemostasis.
Who can participate
Age range18 Years – 100 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Written informed consent from the patient or a surrogate.
* Clinical evidence of severe UGIB.
* Presence of a benign appearing peptic ulcer, anastomotic ulcer, or Dieulafoy's lesion, with some SRH on endoscopy.
* Severe upper GI bleeding.
* Life expectancy of at least 30 days based on lack of severe or terminal comorbidity as judged by the generalist or subspecialist caring for the patient.
Exclusion Criteria:
* Patients who are do-not-resuscitate (DNR) that is not reversible, uncooperative, refuse to participate, or are unable to give consent personally or through a legal surrogate.
* Active GI malignancy, under treatment but not in remission.
* Acute hypovolemic shock that is unresponsive to transfusion of 5 or more units of red blood cells (RBC's) or requires continuous intravenous vasopressor infusion for blood pressure support.
* ASA (American Society of Anesthesiology) class V or higher, moribund, or with a very poor prognosis and expected survival \<30 days.
* Severe coagulopathy or thrombocytopenia despite attempted reversal with transfusion of blood products (e.g persistent International Normalized Ratio \[INR\] \>2.0, platelet count \<20,000, a Partial Thromboplastin Time \[PTT\] greater than 2x upper limit of normal).
* Absolute contraindication to urgent endoscopy (such as suspected perforated viscus, or peritonitis).
* Stricture of the esophagus or pylorus that can not be dilated or precludes passage of a diagnostic sized endoscope and/or…
What they're measuring
1
The rebleeding rate of non-variceal focal UGI lesions
Timeframe: Outcome measure will be assessed at 30 days after participants are enrolled