Clinical trial NCT04741334: Mild Head Injury, Antiplatelets, and Anticoagulants
Official title: Mild Head Injury and Oral Anticoagulants: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Craniocerebral Trauma
Cerebral Hemorrhage
Keywords: Mild head injury
Traumatic cerebral hemorrhage
Direct anticoagulants drugs
Antiplatelets drugs
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 2127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: early Cerebral hemorrhage
timeFrame: 24 hours
measure: skull fracture
timeFrame: 24 hours
measure: Hospital admission
timeFrame: 48 hours
Secondary outcomes:
measure: early mortality
timeFrame: 24 hours
measure: late mortality
timeFrame: 30 days
measure: late cerebral hemorrhage
timeFrame: 30 days
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli - IRCCS
state: Rm
Study officials:
affiliation: Fondazione Policlinico Gemelli
name: Marcello Candelli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: