Mild Head Injury, Antiplatelets, and Anticoagulants

NCT ID: NCT04741334

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2127 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-27
• Study Completion Date: 2022-01-31

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.

Conditions

Craniocerebral Trauma; Cerebral Hemorrhage

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

patients in therapy with direct anticoagulant

Patients presenting in ED with mild head trauma and in therapy with direct anticoagulants

direct anticoagulant

Intervention Type: DRUG

exposure to direct anticoagulant

patients in therapy with oral anticoagulant (dicumarolics)

Patients presenting in ED with mild head trauma and in therapy with oral anticoagulants (dicumarols)

Dicumarols

Intervention Type: DRUG

exposure to dicumarols

patients in therapy with antiplatelet drugs

Patients presenting in ED with mild head trauma and in therapy with antiplatelets

antiplatelet drugs

Intervention Type: DRUG

exposure to antiplatelet drugs

Interventions

direct anticoagulant

exposure to direct anticoagulant

Intervention Type: DRUG

antiplatelet drugs

exposure to antiplatelet drugs

Intervention Type: DRUG

Dicumarols

exposure to dicumarols

Intervention Type: DRUG

Other Intervention Names

DOAC

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

CANDELLI MARCELLO

Adjunct Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcello Candelli, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Gemelli

Locations

Fondazione Policlinico Universitario Agostino Gemelli - IRCCS

Roma, Rm, Italy

Countries

Italy

Other Identifiers

36042/19 2721

Identifier Type: -

Identifier Source: org_study_id