Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04741334
Other study ID # 36042/19 2721
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT02565693 - Apixaban After Anticoagulation-associated Intracerebral Haemorrhage in Patients With Atrial Fibrillation Phase 2
Recruiting NCT01866384 - Targeted Temperature Management After Intracerebral Hemorrhage Phase 2
Completed NCT00029315 - Intraventricular Rt-PA in Patients With Intraventricular Hemorrhage Phase 2
Active, not recruiting NCT06230419 - Retrospective Study on the Direction of Artificial Intelligence in Identifying Cranial Trauma CT Imaging
Not yet recruiting NCT04144868 - Safety and Efficacy of NBO in Acute Intracerebral Hemorrhage N/A
Recruiting NCT05118997 - Active Removal of IntraCerebral Hematoma Via Active Irrigation N/A
Active, not recruiting NCT02258919 - Decompressive Hemicraniectomy in Intracerebral Hemorrhage N/A
Completed NCT01472224 - Volume Measurement and Progression Surveillance of Intracerebral Haemorrhage Using Transcranial Ultrasound N/A
Recruiting NCT06078020 - PLatform Study for INTracerebral Haemorrhage (PLINTH): Community-based Feasibility Study
Completed NCT01467206 - Life After STroke - the LAST Study N/A
Completed NCT00226096 - Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage N/A
Recruiting NCT03815149 - Safety and Clinical Effectiveness of Pipelineā„¢ Shield Devices for Intracranial Aneurysms
Completed NCT00579943 - Regulation of Cerebral Blood Flow in Very Low Birth Weight Infants N/A
Recruiting NCT05424614 - Study on the Prognostic Prediction Model of Patients With Acute Intracerebral Hemorrhage by Artificial Intelligence
Completed NCT03000283 - Conivaptan for the Reduction of Cerebral Edema in Intracerebral Hemorrhage- A Safety and Tolerability Study Phase 1
Active, not recruiting NCT02283879 - Human Umbilical Cord Mesenchymal Stem Cell in Cerebral Hemorrhage Sequela Phase 1
Active, not recruiting NCT02240394 - TCD Detection of Ophthalmic Artery Blood Flow Velocity Prediction Feasibility Study of Intracranial Pressure N/A
Completed NCT01858675 - Biomarkers Correlation With Volemia N/A
Completed NCT00363662 - Diagnostic Utility of MRI in Intracerebral Hemorrhage
Completed NCT03160677 - Blood Pressure Target in Acute Stroke to Reduce hemorrhaGe After Endovascular Therapy N/A