Mild Head Injury, Antiplatelets, and Anticoagulants

Overview

Approximately 20% of MHI patients presenting in PS take antiplatelet agents and 10% take oral anticoagulant therapy. Our study aim is to evaluate the prevalence of cerebral hemorrhage in patients arriving in ED with an MHI. Furthermore, we aim to establish whether the intake of antiplatelet and anticoagulants may represent a risk factor for the onset of cerebral hemorrhage and mortality. A prospective observational study that will include all patients who will refer to the Emergency Department of the Gemelli Polyclinic for an MHI for 2 years. Patients will be divided into four groups based on the use or less of anticoagulants and antiplatelet agents. We will compare the groups to assess the possible increased risk of complications in patients under treatment and between the various drugs.

Full Title of Study: “Mild Head Injury and Oral Anticoagulants: a Prospective Observational Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 27, 2021

Detailed Description

Mild head injury (MHI) is one of the leading causes of access to the emergency room. Approximately 20% of MHI patients presenting in PS with mild brain injury take antiplatelet agents and 10% take oral anticoagulant therapy. The data available to characterize the risk of adverse events in patients with MHI using DOAC are few and of poor quality. Our study aim is to evaluate the prevalence of cerebral hemorrhage in patients arriving in ED with an MHI. Furthermore, we aim to establish whether the intake of antiplatelet and anticoagulants may represent a risk factor for the onset of cerebral hemorrhage and mortality. A prospective observational study that will include all patients who will refer to the Emergency Department of the Gemelli Polyclinic for an MHI for 2 years. Patients will be divided into four groups based on recruitment or less of anticoagulants and antiplatelet agents. We will then determine for each group the prevalence of cerebral hemorrhage, hospitalization, neurosurgical intervention, and mortality at different follow-up times. We will compare the groups to assess the possible increased risk in patients under treatment and between the various drugs. We expect that in head trauma the use of dicumarol anticoagulants and antiplatelet agents is associated with a greater risk of cerebral bleeding compared to DOACs. We also expect that patients taking DOAC have a greater risk of bleeding than patients not undergoing any type of antiplatelet/anticoagulant treatment.

Interventions

  • Drug: direct anticoagulant
    • exposure to direct anticoagulant
  • Drug: antiplatelet drugs
    • exposure to antiplatelet drugs
  • Drug: Dicumarolics
    • exposure to dicumarolics

Arms, Groups and Cohorts

  • patients not in therapy with anticoagulants or antiplatelets drugs
    • Patients presenting in ED with mild head trauma and not in therapy with antiplatelets and/or anticoagulants drugs
  • patients in therapy with direct anticoagulant
    • Patients presenting in ED with mild head trauma and in therapy with direct anticoagulants drugs
  • patients in therapy with oral anticoagulant (dicumarolics)
    • Patients presenting in ED with mild head trauma and in therapy with oral anticoagulants drugs (dicumarolics)
  • patients in therapy with antiplatelet drugs
    • Patients presenting in ED with mild head trauma and in therapy with antiplatelet drugs

Clinical Trial Outcome Measures

Primary Measures

  • early Cerebral hemorrhage
    • Time Frame: 24 hours
    • evidence of cerebral hemorrhage at head CT scan
  • skull fracture
    • Time Frame: 24 hours
    • evidence of skull fracture at head CT scan
  • Hospital admission
    • Time Frame: 48 hours
    • Hospital admission for head trauma complicance

Secondary Measures

  • early mortality
    • Time Frame: 24 hours
    • all cause mortality at 1 days
  • late mortality
    • Time Frame: 30 days
    • all cause mortality at 30 days
  • late cerebral hemorrhage
    • Time Frame: 30 days
    • evidence of cerebral hemorrhage at head CT scan

Participating in This Clinical Trial

Inclusion Criteria

  • Patients presenting with head trauma within 6 hours from the trauma w – Age> 17 years – GCS> 13 (Glasgow Coma Scale) Exclusion Criteria:

  • Presence of serious diseases with a potentially less than one-month prognosis (patient with trauma following syncope from severe cardiovascular disease such as pulmonary embolism, myocardial infarction, ventricular arrhythmias, aortic dissection, aortic aneurysm rupture) – Severe trauma in other body areas (identified in the ED by means of CT of other body areas such as chest CT, abdomen CT, total body CT). – history of congenital or acquired coagulation disorders (Haemophiliacs, patients with severe liver cirrhosis) – Patients undergoing dual antiplatelets drugs or combination therapy of antiplatelet and anticoagulant – Patients presenting with a GCS>13 and with focal neurologic deficits, suspected sunken fracture, or clinical signs of skull base fracture

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marcello Candelli, Adjunct Professor – Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Overall Official(s)
    • Marcello Candelli, MD, PhD, Principal Investigator, Fondazione Policlinico Gemelli
  • Overall Contact(s)
    • Marcello Candelli, Dr, +393472309190, mcandelli@gmail.com

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