Mild Head Injury, Antiplatelets, and Anticoagulants

Completed

• Conditions: Craniocerebral Trauma; Cerebral Hemorrhage
• Interventions: Drug: antiplatelet drugs; Drug: direct anticoagulant; Drug: Dicumarols

• Registration Number: NCT04741334
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief 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.

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 Timeline

• Study Start: 2019-09-27
• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-02-03
• Study First Posted: 2021-02-05
• Primary Completion: 2021-12-31
• Study Completion: 2022-01-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2127

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients in therapy with antiplatelet drugs	antiplatelet drugs	Patients presenting in ED with mild head trauma and in therapy with antiplatelets
patients in therapy with direct anticoagulant	direct anticoagulant	Patients presenting in ED with mild head trauma and in therapy with direct anticoagulants
patients in therapy with oral anticoagulant (dicumarolics)	Dicumarols	Patients presenting in ED with mild head trauma and in therapy with oral anticoagulants (dicumarols)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli - IRCCS; 🇮🇹 Roma, Rm, Italy