Mild Head Injury, Antiplatelets, and Anticoagulants

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Completed

CT.gov ID

NCT04741334

Collaborator

(none)

2,127

Enrollment

Location

28.2

Actual Duration (Months)

75.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Craniocerebral Trauma Cerebral Hemorrhage	Drug: direct anticoagulant Drug: antiplatelet drugs Drug: Dicumarols

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 Design

Study Type:

Observational

Actual Enrollment :

2127 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Mild Head Injury and Oral Anticoagulants: a Prospective Observational Study

Actual Study Start Date :

Sep 27, 2019

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Jan 31, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

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
Hospital admission [48 hours]
Number of participants with hospital admission for head trauma complication

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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