Craniocerebral TraumaNCT04741334
Mild Head Injury, Antiplatelets, and Anticoagulants
An observational study of Craniocerebral Trauma and Cerebral Hemorrhage, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Craniocerebral Trauma, Cerebral Hemorrhage
- What is being tested?
- direct anticoagulant, antiplatelet drugs and Dicumarols
- Type of treatment
- Pill or oral medicine
- How many people
- 2,127 participants
- Where
- 1 siteItaly
- Study dates
- 27 Sep 2019to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients presenting with head trauma within 6 hours from the trauma w
- Age> 17 years
- Glasgow Coma Scale (GCS) > 13
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli - IRCCS
Roma, Rm, 00168
About this study
Official title: Mild Head Injury and Oral Anticoagulants: a Prospective Observational Study
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.
Read the 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 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.
- Conditions
- Craniocerebral Trauma, Cerebral Hemorrhage
- Being tested
- direct anticoagulant, antiplatelet drugs, Dicumarols
- Keywords
- Mild head injury, Traumatic cerebral hemorrhage, Direct anticoagulants drugs, Antiplatelets drugs
- Medical subject headings
- Craniocerebral Trauma, Cerebral Hemorrhage, Cerebral Hemorrhage, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
direct anticoagulantDrug
Also called DOAC
exposure to direct anticoagulant
antiplatelet drugsDrug
exposure to antiplatelet drugs
DicumarolsDrug
exposure to dicumarols
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Drug: Dicumarols | |
| patients in therapy with antiplatelet drugs | Patients presenting in ED with mild head trauma and in therapy with antiplatelets Receives: Drug: antiplatelet drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
early Cerebral hemorrhage
Number of participants with evidence of cerebral hemorrhage at head CT scan
Measured: 24 hours
skull fracture
Number of participants with evidence of skull fracture at head CT scan
Measured: 24 hours
Hospital admission
Number of participants with hospital admission for head trauma complication
Measured: 48 hours
Secondary outcomes (3)
early mortality
Number of participants death from all causes at 1 days
Measured: 24 hours
late mortality
Number of participants death from all causes at 30 days
Measured: 30 days
late cerebral hemorrhage
Number of participants with evidence of cerebral hemorrhage at head CT scan
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start27 Sep 2019
- Primary completion31 Dec 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Craniocerebral TraumaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,127 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CANDELLI MARCELLO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Marcello Candelli, MD, PhD, Principal investigator, Fondazione Policlinico Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741334
- Sponsor's protocol ID
- 36042/19 2721
- Status last verified
- Mar 2022
- First submitted
- 3 Feb 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mild Head Injury and Oral Anticoagulants: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04741334
- Acronym / sponsor ID
- 36042/19 2721
- Conditions
- Craniocerebral Trauma, Cerebral Hemorrhage
- Keywords
- Mild head injury, Traumatic cerebral hemorrhage, Direct anticoagulants drugs, Antiplatelets drugs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,127 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Drug: direct anticoagulantPatients presenting in ED with mild head trauma and in therapy with direct anticoagulants |
| patients in therapy with oral anticoagulant (dicumarolics) | – | Drug: DicumarolsPatients presenting in ED with mild head trauma and in therapy with oral anticoagulants (dicumarols) |
| patients in therapy with antiplatelet drugs | – | Drug: antiplatelet drugsPatients presenting in ED with mild head trauma and in therapy with antiplatelets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients presenting with head trauma within 6 hours from the trauma w
- Age> 17 years
- Glasgow Coma Scale (GCS) > 13
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| direct anticoagulantAlso: DOACexposure to direct anticoagulant | Drug | patients in therapy with direct anticoagulant |
| antiplatelet drugsexposure to antiplatelet drugs | Drug | patients in therapy with antiplatelet drugs |
| Dicumarolsexposure to dicumarols | Drug | patients in therapy with oral anticoagulant (dicumarolics) |
Primary outcome
early Cerebral hemorrhage
Time frame: 24 hours
Number of participants with evidence of cerebral hemorrhage at head CT scan
skull fracture
Time frame: 24 hours
Number of participants with evidence of skull fracture at head CT scan
Hospital admission
Time frame: 48 hours
Number of participants with hospital admission for head trauma complication
3 secondary outcomes
early mortality
Time frame: 24 hours
late mortality
Time frame: 30 days
late cerebral hemorrhage
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcello Candelli, MD, PhD principal investigator
Fondazione Policlinico Gemelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Craniocerebral Trauma and Cerebral Hemorrhage, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early Cerebral hemorrhage (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.