Mild Traumatic Brain Injury and the Risk for Traumatic Intracranial Hemorrhage
NCT ID: NCT05609721
Last Updated: 2022-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
2044 participants
OBSERVATIONAL
2021-01-01
2021-06-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
No Cases of Delayed Intracranial Hemorrhage (d-ICH) Among Patients With Mild Traumatic Brain Injury (mTBI) on Oral Anticoagulation Therapy
NCT05609734
Traumatic Intracranial Hemorrhage in Users of Oral Antithrombotic Drugs
NCT02996851
Study of Antithrombotic Treatment After IntraCerebral Haemorrhage
NCT03186729
Mild Head Injury, Antiplatelets, and Anticoagulants
NCT04741334
Risk Factors of Minor Head Injury
NCT00451789
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Exclusion criteria:
1. high energy trauma,
2. spontaneous hemorrhage,
3. 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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
no intervention, only observational study
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.
no intervention, only observational study
no intervention, only observational study
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
no intervention, only observational study
no intervention, only observational study
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Umeå University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sundsvall Hospital
Sundsvall, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20HSN3790
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.