Mild Head Injury, Antiplatelets, and Anticoagulants

Mild Head Injury and Oral Anticoagulants: a Prospective Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Craniocerebral Trauma; Cerebral Hemorrhage
• Intervention / Treatment: Drug: direct anticoagulant; Drug: Dicumarols; Drug: antiplatelet drugs

Detailed Description

Mild head injury (MHI) is one of the most common causes of emergency department (ED) admission. Approximately 20% of MHI patients admitted to PS with a mild traumatic brain injury is taking antiplatelet medications and 10% is taking oral anticoagulants. There are a few data describing the risk of adverse events in patients with MHI taking direct oral anticoagulants (DOAC), and they are of poor quality.

The aim of this study is to investigate the prevalence of cerebral hemorrhage in patients presenting to the ED with an MHI. Moreover, it will be evaluated 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 the 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 agents. The investigators will then determine the prevalence of cerebral hemorrhage, the need for hospitalization or neurosurgery, and mortality at different follow-up time points for each group. The investigators will compare the groups to assess the potential increased risk in patients on treatment and among drugs.

It can be hypothesized that the use of dicumarol anticoagulants and antiplatelet agents for head injury is associated with a higher risk of cerebral hemorrhage than the use of DOACs. It may be, also, hypothesize that patients taking DOACs are at a higher risk of bleeding than patients not treated with antiplatelet/anticoagulant agents.

• Study Type: Observational
• Enrollment (Actual): 2127

Contacts and Locations

Study Locations

• Italy
  • Rm
    • Roma, Rm, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli - IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Investigators will admit all patients over 18 years of age who present to the emergency department (ED) of the Fondazione Policlinico Gemelli in Rome, who refer to mild head trauma with a Glasgow Coma Scale (GCS) > 13, and who give consent to participate in the study. In all enrolled patients, the investigator will collect blood chemistry tests, especially on coagulation parameters, history of known risk factors present at the time of trauma, data on risk factors present at physical examination, data on CT scans of the head performed during the stay at ED, data on drug therapy taken, and finally data on hospitalization and surgery. Finally, data on a possible one-month follow-up visit will be collected. The follow-up visit is recommended according to the guidelines of a subgroup of these patients. The telephone number for an interview one month after the visit to ED will be collected to evaluate the clinical outcome at 30 days.

Description

Inclusion Criteria:

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

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 Emergency department by means of CT scan 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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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
patients in therapy with direct anticoagulant; Patients presenting in ED with mild head trauma and in therapy with direct anticoagulants	Drug: direct anticoagulant; exposure to direct anticoagulant; Other Names: DOAC
patients in therapy with oral anticoagulant (dicumarolics); Patients presenting in ED with mild head trauma and in therapy with oral anticoagulants (dicumarols)	Drug: Dicumarols; exposure to dicumarols
patients in therapy with antiplatelet drugs; Patients presenting in ED with mild head trauma and in therapy with antiplatelets	Drug: antiplatelet drugs; exposure to antiplatelet drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
early Cerebral hemorrhage	Number of participants with evidence of cerebral hemorrhage at head CT scan	24 hours
skull fracture	Number of participants with evidence of skull fracture at head CT scan	24 hours
Hospital admission	Number of participants with hospital admission for head trauma complication	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
early mortality	Number of participants death from all causes at 1 days	24 hours
late mortality	Number of participants death from all causes at 30 days	30 days
late cerebral hemorrhage	Number of participants with evidence of cerebral hemorrhage at head CT scan	30 days

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Marcello Candelli, MD, PhD, Fondazione Policlinico Gemelli

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 27, 2019
• Primary Completion (ACTUAL): December 31, 2021
• Study Completion (ACTUAL): January 31, 2022

Study Registration Dates

• First Submitted: February 3, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (ACTUAL): February 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Mild head injury; Traumatic cerebral hemorrhage; Direct anticoagulants drugs; Antiplatelets drugs
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage; Craniocerebral Trauma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Uncoupling Agents; Anticoagulants; Platelet Aggregation Inhibitors; Dicumarol
• Other Study ID Numbers: 36042/19 2721

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: Six months after publication
• IPD Sharing Access Criteria: By request to the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No