Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03669068
Other study ID # HRC-ENDOHEM-02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date May 30, 2020

Study information

Verified date July 2020
Source Hospital Universitario Ramon y Cajal
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1602
Est. completion date May 30, 2020
Est. primary completion date April 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age >= 18 years.

- Patients with preoperative use of oral anticoagulants (Vitamin K antagonist, apixaban, edoxaban, rivaroxaban or dabigatrán) undergoing gastrointestinal endoscopy.

- Patients on oral anticoagulants (Vitamin K antagonist, apixaban, edoxaban, rivaroxaban or dabigatran) presenting with gastrointestinal bleeding, regardless of receiving gastrointestinal endoscopy.

- Signed informed consent.

Exclusion Criteria:

- Negative to participate in the study.

Study Design


Intervention

Procedure:
Gastrointestinal endoscopy
Two separated groups will be included in the registry: Patients with oral anticoagulants-induced gastrointestinal bleeding unrelated to an endoscopic procedure. Patients undergoing elective gastrointestinal endoscopy.

Locations

Country Name City State
Spain Hospital Universitario Ramón y Cajal Madrid

Sponsors (12)

Lead Sponsor Collaborator
Hospital Universitario Ramon y Cajal Hospital Clinic of Barcelona, Hospital de Avilés, Hospital de Viladecans, Hospital del Mar, Hospital General de Granollers, Hospital General de Villalba, Hospital Sant Pau, Hospital Universitario 12 de Octubre, Hospital Universitario Central de Asturias, Puerta de Hierro University Hospital, University of Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 months
Secondary Incidence of therapeutic endoscopy-related gastrointestinal bleeding Nº of patients during the study period presenting with therapeutic endoscopy-related gastrointestinal bleeding 3 months
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05060731 - Iron Supplementation in Upper Non-variceal Gastrointestinal Bleeding Phase 4
Recruiting NCT05949268 - Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Small Bowel
Not yet recruiting NCT03243240 - Computed Tomography in Gastrointestinal Bleeding N/A
Completed NCT02595853 - Efficacy of a Novel Hemostatic Powder in GI Bleeding
Completed NCT01434108 - Effects of the Administration of Ornithine Phenylacetate in Patients With Cirrhosis and Upper Gastrointestinal Bleeding Phase 2/Phase 3
Terminated NCT01756690 - Predicting Lung Injury From Transfusion in Patients With Liver Disease N/A
Completed NCT01424254 - The Effectiveness of Video-capsule Endoscopy in Gastrointestinal Bleeding of Obscure Origin Phase 3
Completed NCT05884931 - Effectiveness and Safety of Nexpowder as an Endoscopic Hemostatic Treatment N/A
Completed NCT01335516 - Follow-up of Glypressin (Terlipressin) Clinical Efficacy in the Treatment of Bleeding Oesophageal Varices N/A
Withdrawn NCT00401908 - Factors Contributing To Cardiovascular Morbidity and Mortality in Patients With Gastrointestinal Bleeding N/A
Recruiting NCT05024864 - HELicobacter Pylori Screening to Prevent Gastrointestinal Bleeding in MI Patients N/A
Completed NCT05008640 - Creation of an E-toileting Log Through Classification of the Physical Properties of Stool and Urine Using TrueLoo™
Recruiting NCT06259292 - Comprehensive HHT Outcomes Registry of the United States (CHORUS)
Completed NCT03716466 - Evaluation of Prophylactic Endotracheal Intubation
Completed NCT05362227 - High-Volume Vs Low-Volume Preparation in Emergency Department N/A
Completed NCT02405286 - Prospective Assessment of the Rockall Risk ScoringSystem in Patients With Upper Gastrointestinal Hemorrhage N/A
Recruiting NCT00562445 - Adrenal Insufficiency in Critical Emergencies in Digestive Diseases N/A
Recruiting NCT05290857 - Anticoagulation After GI Bleeding Pilot Study and Registry N/A
Recruiting NCT02863250 - Australian and New Zealand Massive Transfusion Registry
Completed NCT01415869 - Occult Gastrointestinal Bleeding in Non-pulsatile Left Ventricular Assist Device(VAD)Patients