Traumatic Intracranial HemorrhageNCT05609721
Mild Traumatic Brain Injury and the Risk for Traumatic Intracranial Hemorrhage
An observational study of Traumatic Intracranial Hemorrhage and Brain Injuries, run by Umeå University at 1 site in Sweden.
Trial summary
Management of traumatic brain injuries causes significant efforts on emergency departments (ED) and overall health care. Patients on antithrombotic treatment with even minor trauma to the head, although without significant clinical findings, represent special challenges because the risk of traumatic intracranial… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Traumatic Intracranial Hemorrhage, Brain Injuries
- How many people
- 2,044 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2021to 20 Jun 2021
- 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 Any age
- Child, Adult, Older adult
Study population: This is a retrospective observational study investigating intracranial hemorrhage in patients with mTBI in Sundsvall hospital. The city is located on the east coast of northern Sweden and is the 20th largest municipality which serves a population of about 100 000 people. The studied period was between Jan 1st 2018 till May 30th 2020 and data collection was done by two persons following a predetermined protocol. Hospital's radiology registry and patient journals were used to find relevant participants. CT-scan referrals from surgical branch of the emergency department and acute surgical department, suspecting traumatic brain hemorrhage, were read. Mechanism of injury, pre-injury antithrombotic treatment and patient arrival status was subsequently retrieved from patient medical journals using social security number identified in the earlier step.
Who may be able to join
- Patients that fulfilled following criteria were included (1) low energy traumas to the head, (2) pre-injury antithrombotic treatment, (3) > 18 years, (4) reaction level scale (RLS) < 3. Since data collection started at the hospital's radiology registry, we could easily retrieve all patients with low energy traumas to the head who underwent CT scans, were we also included patients without any pre-injury treatment for comparison.
Who cannot join
- Exclusion criteria were (1) high energy trauma, (2) spontaneous hemorrhage, (3) concealed journals.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mild Traumatic Brain Injury and the Risk for Traumatic Intracranial Hemorrhage in Patients on Oral Antithrombotic Therapy
Management of traumatic brain injuries causes significant efforts on emergency departments (ED) and overall health care. Patients on antithrombotic treatment with even minor trauma to the head, although without significant clinical findings, represent special challenges because the risk of traumatic intracranial hemorrhage (tICH) with these agents. The aim of this study was to compare the prevalence of tICH in patients on various pre-injury antithrombotic treatment exposed to minor Traumatic Brain injuries (mTBI) in Sundsvall with untreated patients. Secondary aim was to explore different risk factors for tICH.
Data from medical records and radiology registry with mTBI in Sundsvall hospital between 2018-2020 in Sundsvall identified 2044 patients. Demographic data, pre-injury medications with antithrombotic treatment, state of consciousness at admission and the results of CT-scans of brain was investigated.
Read the detailed description
Inclussion criteria:
- low energy traumas to the head,
- pre-injury antithrombotic treatment,
- > 18 years,
- reaction level scale (RLS) < 3.
Since data collection started at the hospital's radiology registry, we could easily retrieve all patients with low energy traumas to the head who underwent CT scans, were we also included patients without any pre-injury treatment for comparison.
Exclusion criteria:
- high energy trauma,
- spontaneous hemorrhage,
- concealed journals.
This is a retrospective observational study investigating intracranial hemorrhage in patients with mTBI in Sundsvall hospital. The city is located on the east coast of northern Sweden and is the 20th largest municipality which serves a population of about 100 000 people. The studied period was between Jan 1st 2018 till May 30th 2020 and data collection was done by two persons following a predetermined protocol.
Hospital's radiology registry and patient journals were used to find relevant participants. CT-scan referrals from surgical branch of the emergency department and acute surgical department, suspecting traumatic brain hemorrhage, were read. Mechanism of injury, pre-injury antithrombotic treatment and patient arrival status was subsequently retrieved from patient medical journals using social security number identified in the earlier step.
mTBI is defined by Scandinavian guidelines as a GCS score of 14, or 15 if the patient also has either suspected/confirmed loss of consciousness, repeated vomiting, posttraumatic seizures, focal neurological deficits, signs of skull fracture, shunt-treated hydrocephalus, therapeutic anticoagulation or both > 65 and antiplatelet medication [3]. GCS is not widely used in Sundsvall ED. Instead, Reaction level scale was chosen because of its more regular use. For comparison between the two scales, GCS 15 and RLS 1, and GCS 3 and RLS 8 are fully comparable. GCS 8 and RLS 4 are roughly comparable and are considered as an indication for intubation. If neither scale was utilized the patient was included if consciousness given in the patients´ journal was unaltered.
High energy trauma was defined as any traffic accident or fall > 3 meters, or other unstable patients who underwent immediate trauma care by a full trauma team. These patients often present themselves with multiple organ injury which was not within the scope of this study.
Patients < 18 years of age and patients with concealed journals were excluded because of legal and practical reasons.
Demographic variables collected was age and gender. Severity of head trauma, treatment with anticoagulation therapy (DOAC/VKA/LMWH/other) and/or antiplatelet treatment (ASA/clopidogrel/ticagrelor/other) were noted. To make definitions clear, antithrombotic treatment is used as an overall term to include both anticoagulation therapy and antiplatelet treatments. tICH was categorized as subdural, subarachnoid, epidural, and other.
Statistical analysis was executed using IBM® SPSS® Statistics version 27 for Microsoft Windows®. Demographic data were presented as means and standard deviations (SD), or as counts and percentage where appropriate. Comparisons between different groups' patient characteristics were performed with Pearson's χ2 test (for categorical variables), or independent-samples Student's t test or Mann-Whitney-Wilcoxon U-test (for continuous variables). P-values < 0.05 were considered significant. Significant parameters in group comparisons were inserted in a multivariate logistic regression model.
The sample size was estimated by the study supervisors to match comparable studies in the field, and to assure an adequate number of patients to examine the risk of dICH which we discuss in a separate paper. Since dICH is a much rarer condition, we found that patients included would be sufficient for this question at issue. Hence, power calculation prior to study start was done.
- Conditions
- Traumatic Intracranial Hemorrhage, Brain Injuries
- Being tested
- no intervention, only observational study
- Medical subject headings
- Intracranial Hemorrhage, Traumatic, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention, only observational studyOther
no intervention, only observational study
| Study group | Role | What they receive |
|---|---|---|
| Patients with antithromotic therapy | Data from medical records and radiology registry with mTBI in Sundsvall hospital between 2018-2020 in Sundsvall identified 2044 patients. Demographic data, pre-injury medications with antithrombotic treatment, state of consciousness at admission and the results of CT-scans of brain was investigated. Receives: Other: no intervention, only observational study | |
| Patients without antothrombotic therapy | Data from medical records and radiology registry with mTBI in Sundsvall hospital between 2018-2020 in Sundsvall identified 2044 patients. Demographic data, pre-injury medications with antithrombotic treatment, state of consciousness at admission and the results of CT-scans of brain was investigated. Receives: Other: no intervention, only observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
traumatic Intracranial hemorrhage
In this retrospective study, all CT-scan referrals from surgical branch of the emergency department and acute surgical department, suspecting traumatic brain hemorrhage, were included. The studied period was between Jan 1st 2018 till May 30th 2020. Patients with an traumatic Intracranial hemorrhage were subcategorized into subdural, subarachnoid, epidural, and other.
Measured: Jan 1st 2018 till May 30th 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start1 Jan 2021
- Primary completion30 Mar 2021
- Study completion20 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Intracranial HemorrhageStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe 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
- Retrospective
- Enrolment
- 2,044 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609721
- Sponsor's protocol ID
- 20HSN3790
- Status last verified
- Oct 2022
- First submitted
- 13 Oct 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mild Traumatic Brain Injury and the Risk for Traumatic Intracranial Hemorrhage in Patients on Oral Antithrombotic Therapy
- ClinicalTrials.gov ID
- NCT05609721
- Acronym / sponsor ID
- 20HSN3790
- Conditions
- Traumatic Intracranial Hemorrhage, Brain Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,044 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 20 Jun 2021 (actual)
- First posted
- 8 Nov 2022 (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.
Management of traumatic brain injuries causes significant efforts on emergency departments (ED) and overall health care. Patients on antithrombotic treatment with even minor trauma to the head, although without significant clinical findings, represent special challenges because the risk of traumatic intracranial hemorrhage (tICH) with these agents. The aim of this study was to compare the prevalence of tICH in patients on various pre-injury antithrombotic treatment exposed to minor Traumatic Brain injuries (mTBI) in Sundsvall with untreated patients. Secondary aim was to explore different risk factors for tICH.
Data from medical records and radiology registry with mTBI in Sundsvall hospital between 2018-2020 in Sundsvall identified 2044 patients. Demographic data, pre-injury medications with antithrombotic treatment, state of consciousness at admission and the results of CT-scans of brain was investigated.
Detailed description
Inclussion criteria:
- low energy traumas to the head,
- pre-injury antithrombotic treatment,
- > 18 years,
- reaction level scale (RLS) < 3.
Since data collection started at the hospital's radiology registry, we could easily retrieve all patients with low energy traumas to the head who underwent CT scans, were we also included patients without any pre-injury treatment for comparison.
Exclusion criteria:
- high energy trauma,
- spontaneous hemorrhage,
- concealed journals.
This is a retrospective observational study investigating intracranial hemorrhage in patients with mTBI in Sundsvall hospital. The city is located on the east coast of northern Sweden and is the 20th largest municipality which serves a population of about 100 000 people. The studied period was between Jan 1st 2018 till May 30th 2020 and data collection was done by two persons following a predetermined protocol.
Hospital's radiology registry and patient journals were used to find relevant participants. CT-scan referrals from surgical branch of the emergency department and acute surgical department, suspecting traumatic brain hemorrhage, were read. Mechanism of injury, pre-injury antithrombotic treatment and patient arrival status was subsequently retrieved from patient medical journals using social security number identified in the earlier step.
mTBI is defined by Scandinavian guidelines as a GCS score of 14, or 15 if the patient also has either suspected/confirmed loss of consciousness, repeated vomiting, posttraumatic seizures, focal neurological deficits, signs of skull fracture, shunt-treated hydrocephalus, therapeutic anticoagulation or both > 65 and antiplatelet medication [3]. GCS is not widely used in Sundsvall ED. Instead, Reaction level scale was chosen because of its more regular use. For comparison between the two scales, GCS 15 and RLS 1, and GCS 3 and RLS 8 are fully comparable. GCS 8 and RLS 4 are roughly comparable and are considered as an indication for intubation. If neither scale was utilized the patient was included if consciousness given in the patients´ journal was unaltered.
High energy trauma was defined as any traffic accident or fall > 3 meters, or other unstable patients who underwent immediate trauma care by a full trauma team. These patients often present themselves with multiple organ injury which was not within the scope of this study.
Patients < 18 years of age and patients with concealed journals were excluded because of legal and practical reasons.
Demographic variables collected was age and gender. Severity of head trauma, treatment with anticoagulation therapy (DOAC/VKA/LMWH/other) and/or antiplatelet treatment (ASA/clopidogrel/ticagrelor/other) were noted. To make definitions clear, antithrombotic treatment is used as an overall term to include both anticoagulation therapy and antiplatelet treatments. tICH was categorized as subdural, subarachnoid, epidural, and other.
Statistical analysis was executed using IBM® SPSS® Statistics version 27 for Microsoft Windows®. Demographic data were presented as means and standard deviations (SD), or as counts and percentage where appropriate. Comparisons between different groups' patient characteristics were performed with Pearson's χ2 test (for categorical variables), or independent-samples Student's t test or Mann-Whitney-Wilcoxon U-test (for continuous variables). P-values < 0.05 were considered significant. Significant parameters in group comparisons were inserted in a multivariate logistic regression model.
The sample size was estimated by the study supervisors to match comparable studies in the field, and to assure an adequate number of patients to examine the risk of dICH which we discuss in a separate paper. Since dICH is a much rarer condition, we found that patients included would be sufficient for this question at issue. Hence, power calculation prior to study start was done.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with antithromotic therapy | – | Other: no intervention, only observational studyData from medical records and radiology registry with mTBI in Sundsvall hospital between 2018-2020 in Sundsvall identified 2044 patients. Demographic data, pre-injury medications with antithrombotic treatment, state of consciousness at admission and the results of CT-scans of brain was investigated. |
| Patients without antothrombotic therapy | – | Other: no intervention, only observational studyData from medical records and radiology registry with mTBI in Sundsvall hospital between 2018-2020 in Sundsvall identified 2044 patients. Demographic data, pre-injury medications with antithrombotic treatment, state of consciousness at admission and the results of CT-scans of brain was investigated. |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- This is a retrospective observational study investigating intracranial hemorrhage in patients with mTBI in Sundsvall hospital. The city is located on the east coast of northern Sweden and is the 20th largest municipality which serves a population of about 100 000 people. The studied period was between Jan 1st 2018 till May 30th 2020 and data collection was done by two persons following a predetermined protocol. Hospital's radiology registry and patient journals were used to find relevant participants. CT-scan referrals from surgical branch of the emergency department and acute surgical department, suspecting traumatic brain hemorrhage, were read. Mechanism of injury, pre-injury antithrombotic treatment and patient arrival status was subsequently retrieved from patient medical journals using social security number identified in the earlier step.
Key inclusion criteria (1 listed)
- Patients that fulfilled following criteria were included (1) low energy traumas to the head, (2) pre-injury antithrombotic treatment, (3) > 18 years, (4) reaction level scale (RLS) < 3. Since data collection started at the hospital's radiology registry, we could easily retrieve all patients with low energy traumas to the head who underwent CT scans, were we also included patients without any pre-injury treatment for comparison.
Key exclusion criteria (1 listed)
- Exclusion criteria were (1) high energy trauma, (2) spontaneous hemorrhage, (3) concealed journals.
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 |
|---|---|---|
| no intervention, only observational studyno intervention, only observational study | Other | Patients with antithromotic therapy, Patients without antothrombotic therapy |
Primary outcome
traumatic Intracranial hemorrhage
Time frame: Jan 1st 2018 till May 30th 2020
In this retrospective study, all CT-scan referrals from surgical branch of the emergency department and acute surgical department, suspecting traumatic brain hemorrhage, were included. The studied period was between Jan 1st 2018 till May 30th 2020. Patients with an traumatic Intracranial hemorrhage were subcategorized into subdural, subarachnoid, epidural, and other.
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 8 Nov 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Traumatic Intracranial Hemorrhage and Brain Injuries, run by Umeå University at 1 site in Sweden.
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 1 inclusion and 1 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 8 Nov 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 Sweden. 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?
traumatic Intracranial hemorrhage (time frame: Jan 1st 2018 till May 30th 2020). 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 8 Nov 2022.