HemoPill Acute ® in Suspected Nonvariceal Upper Gastrointestinal Bleeding
Germany73 participantsStarted 2020-10-08
Plain-language summary
The study examines, whether the use of the HemoPill Acute ® capsule in case of suspected nonvariceal upper gastrointestinal bleeding can identify cases in which endoscopy can be delayed to 48-96 hours without risk to the patient.
Who can participate
Age range18 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:
* Emergency presentation with clinical suspicion of non-variceal upper GI bleeding (e.g. haematin vomiting, melena, etc.)
* hemodynamic stable patient (heart rate \<100 / min, Blood pressure sys ≥ 100mmHg)
* Emergency endoscopy indicated (modified Glasgow-Blatchford-Score ≥ 2 points)
* Administration of proton pump inhibitors possible (no allergy known)
* Good communication (without translator) with the study doctor and fulfill all requirements of the study
* Written consent after detailed information about the study
Exclusion Criteria:
* Hemodynamically unstable patients (HF\> 100 / min, RR \<100mmHg despite fluid administration) with indication for endoscopy within 12 hours
* Indication for endoscopy within 12 hours recommended by endoscopy call service
* Clinical suspicion of variceal bleeding of the upper GI tract (risk factors according to german guidelines: cirrhosis of the liver, splanchnic thrombosis, thrombocytopenia, known increased liver / spleen stiffness, known esophageal varices)
* Clinical suspicion of lower GI bleeding (e.g. hematochezia)
* Vomiting blood (hematemesis observed by the emergency doctor or in the clinic)
* Patients with inflammatory bowel disease (Crohn's disease or ulcerative colitis)
* Severe acute and chronic organ diseases that need treatment (e.g. kidney replacement treatment) (ASA ≥4)
* Changed anatomy of the upper GI tract (e.g. gastric resection)
* Known or suspected gastrointestinal obstructions, strictures, fistul…
What they're measuring
1
Rate of avoided emergency endoscopies (usually done within 24 hours) in case of negative HemoPill.
Timeframe: 48 to 96 hours after swallow the capsule