Status:
COMPLETED
Mild Head Injury, Antiplatelets, and Anticoagulants
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Craniocerebral Trauma
Cerebral Hemorrhage
Eligibility:
All Genders
18+ years
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 determin...
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 antiplatel...
Eligibility Criteria
Inclusion
- Patients presenting with head trauma within 6 hours from the trauma w
- Age\> 17 years
- Glasgow Coma Scale (GCS) \> 13
Exclusion
- 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
Key Trial Info
Start Date :
September 27 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 31 2022
Estimated Enrollment :
2127 Patients enrolled
Trial Details
Trial ID
NCT04741334
Start Date
September 27 2019
End Date
January 31 2022
Last Update
March 31 2022
Active Locations (1)
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1
Fondazione Policlinico Universitario Agostino Gemelli - IRCCS
Roma, Rm, Italy, 00168