Status:
COMPLETED
HemoPill Acute ® in Suspected Nonvariceal Upper Gastrointestinal Bleeding
Lead Sponsor:
Wuerzburg University Hospital
Collaborating Sponsors:
Vivantes Netzwerk für Gesundheit GmbH
University Hospital Freiburg
Conditions:
Upper Gastrointestinal Bleeding
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
Despite a variety of scoring systems (Glasgow-Blatchford-Score, etc.) timing of endoscopy in case of suspecting nonvariceal bleeding in the upper gastrointestinal tract is still challenging. While ve...
Eligibility Criteria
Inclusion
- 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
- 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, fistulas or known diverticula
- Dysphagia or other swallowing disorders
- Awareness restrictions that make it impossible to swallow the HemoPill Acute ® capsule on your own
- Patients with pacemakers, defibrillators, or other implantable electromedical devices
- Known allergy to parylene (capsule surface)
- Soon MRI scan planned
- Pregnancy or breastfeeding
- Mental impairment that limits the ability to meet all study requirements.
Key Trial Info
Start Date :
October 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2024
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT04472364
Start Date
October 8 2020
End Date
April 8 2024
Last Update
July 10 2024
Active Locations (4)
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1
Klinikum Friedrichshain
Berlin, Germany, 10249
2
Universitästklinik Freiburg
Freiburg im Breisgau, Germany, 79106
3
Sana Klinikum Offenbach GmbH
Offenbach, Germany, 63069
4
Universitätsklinik Würzburg
Würzburg, Germany, 97080