Mild Head Injury, Antiplatelets, and Anticoagulants

NCT04741334 | Completed

• 1 other identifier: 36042/19 2721
• Study Type: observational
• Target: 2,127
• Locations: 1 country
• Sites: 1

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.

Conditions

Craniocerebral Trauma; Cerebral Hemorrhage

Keywords

Mild head injury; Traumatic cerebral hemorrhage; Direct anticoagulants drugs; Antiplatelets drugs

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• early mortality

  24 hours

• late mortality

  30 days

• late cerebral hemorrhage

  30 days

Study Arms (4)

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

Drug: direct anticoagulant

patients in therapy with oral anticoagulant (dicumarolics)

Patients presenting in ED with mild head trauma and in therapy with oral anticoagulants (dicumarols)

Drug: Dicumarols

patients in therapy with antiplatelet drugs

Patients presenting in ED with mild head trauma and in therapy with antiplatelets

Drug: antiplatelet drugs

Interventions

direct anticoagulant DRUG

exposure to direct anticoagulant

Also known as: DOAC

patients in therapy with direct anticoagulant

antiplatelet drugs DRUG

exposure to antiplatelet drugs

patients in therapy with antiplatelet drugs

Dicumarols DRUG

exposure to dicumarols

patients in therapy with oral anticoagulant (dicumarolics)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients presenting with head trauma within 6 hours from the trauma w
• Age\> 17 years
• Glasgow Coma Scale (GCS) \> 13

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli - IRCCS

Roma, Rm, 00168, Italy

Location

MeSH Terms

Conditions

Craniocerebral Trauma; Cerebral Hemorrhage; Cerebral Hemorrhage, Traumatic

Interventions

Factor Xa Inhibitors; Platelet Aggregation Inhibitors

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Hemorrhage, Traumatic; Brain Injuries; Intracranial Hemorrhage, Traumatic

Intervention Hierarchy (Ancestors)

Antithrombins; Serine Proteinase Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Anticoagulants; Hematologic Agents; Therapeutic Uses

Study Officials

• Marcello Candelli, MD, PhD

  Fondazione Policlinico Gemelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 5, 2021
• Study Start: September 27, 2019
• Primary Completion: December 31, 2021
• Study Completion: January 31, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Six months after publication
• Access Criteria: By request to the corresponding author

Locations

IT (1)