Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05609721 |
| Other study ID # |
20HSN3790 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2021 |
| Est. completion date |
June 20, 2021 |
Study information
| Verified date |
October 2022 |
| Source |
Umeå University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
Description:
Inclussion criteria:
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.
