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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| patients in therapy with oral anticoagulant (dicumarolics) | Patients presenting in ED with mild head trauma and in therapy with oral anticoagulants (dicumarols) |
| |
| patients in therapy with antiplatelet drugs | Patients presenting in ED with mild head trauma and in therapy with antiplatelets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| direct anticoagulant | Drug | exposure to direct anticoagulant |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Marcello Candelli, MD, PhD | Fondazione Policlinico Gemelli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli - IRCCS | Roma | Rm | 00168 | Italy |
all IPD that underlie results in a publication
Six months after publication
By request to the corresponding author
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| ID | Term |
|---|---|
| D006259 | Craniocerebral Trauma |
| D002543 | Cerebral Hemorrhage |
| D020202 | Cerebral Hemorrhage, Traumatic |
| ID | Term |
|---|---|
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D020300 | Intracranial Hemorrhages |
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| ID | Term |
|---|---|
| D065427 | Factor Xa Inhibitors |
| D010975 | Platelet Aggregation Inhibitors |
| ID | Term |
|---|---|
| D000991 | Antithrombins |
| D015842 | Serine Proteinase Inhibitors |
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
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| antiplatelet drugs | Drug | exposure to antiplatelet drugs |
|
| Dicumarols | Drug | exposure to dicumarols |
|
| 30 days |
| late cerebral hemorrhage | Number of participants with evidence of cerebral hemorrhage at head CT scan | 30 days |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020201 | Brain Hemorrhage, Traumatic |
| D001930 | Brain Injuries |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D045504 |
| Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000925 | Anticoagulants |
| D006401 | Hematologic Agents |
| D045506 | Therapeutic Uses |