Mild Head Injury, Antiplatelets, and Anticoagulants

Cerebral Hemorrhage Clinical Trial

Official title:

Mild Head Injury and Oral Anticoagulants: a Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04741334
• Other study ID #: 36042/19 2721
• Status: Completed
• Start date: September 27, 2019
• Est. completion date: January 31, 2022

Study information

• Verified date: March 2022
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2127
• Est. completion date: January 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Craniocerebral Trauma
• Hemorrhage

Intervention

Drug:
• direct anticoagulant
exposure to direct anticoagulant
• antiplatelet drugs
exposure to antiplatelet drugs
• Dicumarols
exposure to dicumarols

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli - IRCCS	Roma	Rm

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	early Cerebral hemorrhage	Number of participants with evidence of cerebral hemorrhage at head CT scan	24 hours
Primary	skull fracture	Number of participants with evidence of skull fracture at head CT scan	24 hours
Primary	Hospital admission	Number of participants with hospital admission for head trauma complication	48 hours
Secondary	early mortality	Number of participants death from all causes at 1 days	24 hours
Secondary	late mortality	Number of participants death from all causes at 30 days	30 days
Secondary	late cerebral hemorrhage	Number of participants with evidence of cerebral hemorrhage at head CT scan	30 days