An observational study in Gastrointestinal Bleeding, Cardiovascular Complication and Anticoagulants; Circulating, Hemorrhagic Disorder, sponsored by Hospital Universitario Ramon y Cajal. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-31.
Sponsored by Hospital Universitario Ramon y Cajal · Observational
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.
339 studies on the registry are indexed under Gastrointestinal Hemorrhage; 79 are open to participants now.
This study's enrollment of 1,602 is above the median of 200 across 116 observational studies indexed under Gastrointestinal Hemorrhage.
Browse Gastrointestinal Hemorrhage studies →Hospital Universitario Ramon y Cajal is the lead sponsor of 29 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients on oral anticoagulants (Vitamin K antagonist, apixaban, edoxaban, rivaroxaban or dabigatran)
Exclusion Criteria:
Patients undergoing gastrointestinal endoscopy unrelated to anticoagulant-induced gastrointestinal bleeding.
Procedure: Gastrointestinal endoscopy
Patients with anticoagulant-induced gastrointestinal bleeding will be analyzed separately
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.
Incidence of Cardiovascular events
Nº of patients during the study period presenting with a cardiovascular event, defined as any of the following entities: pulmonary thromboembolism, venous thromboembolism, acute coronary syndrome, arterial peripheral embolism or cerebrovascular accident.
Time frame: 3 months
Incidence of therapeutic endoscopy-related gastrointestinal bleeding
Nº of patients during the study period presenting with therapeutic endoscopy-related gastrointestinal bleeding
Time frame: 3 months
Plan to share: Yes
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Hospital Universitario Ramon y Cajal