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Mild Head Injury, Antiplatelets, and Anticoagulants

NCT04741334 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2127

Last updated 2022-03-31

No results posted yet for this study

Summary

Approximately 20% of patients with mild head injury presenting to the Emergency Department (ED) is taking antiplatelet agents and 10% is taking oral anticoagulants. The aim of the study is to determine the prevalence of cerebral hemorrhage in patients presenting to the ED with an MHI. It also aims to determine whether the use of antiplatelet agents and anticoagulants may be a risk factor for the occurrence of cerebral hemorrhage and mortality. This is a prospective observational study that will include all patients who present to ED at Gemelli Hospital for an MHI for 2 years. Patients will be divided into four groups according to whether or not they are taking anticoagulants and antiplatelet drugs. Groups will be compared to evaluate the possible increased risk of complications in patients on treatment and among the different medications.

Conditions

  • Craniocerebral Trauma
  • Cerebral Hemorrhage

Interventions

DRUG

direct anticoagulant

exposure to direct anticoagulant

DRUG

antiplatelet drugs

exposure to antiplatelet drugs

DRUG

Dicumarols

exposure to dicumarols

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Marcello Candelli, MD, PhD · Fondazione Policlinico Gemelli

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-27
Primary Completion
2021-12-31
Completion
2022-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04741334 on ClinicalTrials.gov