Trials / Completed
CompletedNCT03669068
Gastrointestinal Endoscopy in Patients With Prothrombotic Conditions: THE ENDOHEM REGISTRY
Gastrointestinal Endoscopy in Patients With Prothrombotic Conditions: A Prospective, Multicentre, and Observational Registry
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,602 (actual)
- Sponsor
- Hospital Universitario Ramon y Cajal · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This observational study evaluates the safety of gastrointestinal endoscopy in patients on oral anticoagulants (Vitamin K antagonists, rivaroxaban, dabigatran, edoxaban, and apixaban). This registry aims to assess the incidence, characteristics and risk factors for cardiovascular and bleeding events associated with an endoscopic procedure. Besides, it aims to evaluate the differences between Vitamin K antagonists and DOACs users and to estimate the impact of anticoagulation withdrawal time on the primary and secondary outcomes.
Conditions
- Gastrointestinal Bleeding
- Cardiovascular Complication
- Anticoagulants; Circulating, Hemorrhagic Disorder
- Gastrointestinal Endoscopy
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Gastrointestinal endoscopy | Two separated groups will be included in the registry: 1. Patients with oral anticoagulants-induced gastrointestinal bleeding unrelated to an endoscopic procedure. 2. Patients undergoing elective gastrointestinal endoscopy. |
Timeline
- Start date
- 2018-01-01
- Primary completion
- 2020-04-01
- Completion
- 2020-05-30
- First posted
- 2018-09-13
- Last updated
- 2020-07-31
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT03669068. Inclusion in this directory is not an endorsement.