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OpenTrials
Completed

NCT Number: NCT03669068

Gastrointestinal Endoscopy in Patients With Prothrombotic Conditions: THE ENDOHEM REGISTRY

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.

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Key information

Conditions

Gastrointestinal Bleeding Anticoagulants; Circulating, Hemorrhagic Disorder Cardiovascular Complication Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Endoscopy Gastrointestinal Hemorrhage Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gastrointestinal Endoscopy

Procedure

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.

Primary outcomes

  1. Incidence of Cardiovascular events

    Time frame: 3 months

    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.

Secondary outcomes

  1. Incidence of therapeutic endoscopy-related gastrointestinal bleeding

    Time frame: 3 months

    Nº of patients during the study period presenting with therapeutic endoscopy-related gastrointestinal bleeding

Sponsors and collaborators

Lead sponsor

Hospital Universitario Ramon y Cajal

Other

Collaborators

  • Hospital Clinic of Barcelona
  • Hospital General de Granollers
  • Hospital General de Villalba
  • Hospital Sant Pau
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario Central de Asturias
  • Hospital de Avilés
  • Hospital de Viladecans
  • Hospital del Mar
  • Puerta de Hierro University Hospital
  • University of Salamanca

Registry information

Official study title

Gastrointestinal Endoscopy in Patients With Prothrombotic Conditions: A Prospective, Multicentre, and Observational Registry

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 13, 2018
Registry last updated
Jul 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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