Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05609734 |
| Other study ID # |
20HSN3790 nr2 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2021 |
| Est. completion date |
April 15, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
Umeå University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Abstract Purpose Patients with anticoagulation therapy has a higher risk of developing
traumatic Intracranial Hemorrhage (tICH). Delayed Intracranial Hemorrhage (d-ICH) is a rarer
clinical manifestation; however, the incidence varies from 0-9,6 % in other studies. Some
studies have also questioned the clinical relevance of d-ICH, since the mortality and the
need of neurosurgical intervention is reported to be very low. The aim of this study is to
determine the incidence of d-ICH at Sundsvall Regional Hospital.
Methods A retrospective observational study of patients with mTBI and oral anticoagulation
therapy. Data from medical records and radiology registry in Sundsvall hospital for 29 months
during 2018-2020 in Sundsvall identified 249 patients with an initial negative CT scan who
performed a follow-up CT scan. Outcome measure was incidence of d-ICH.
Description:
Method This is a retrospective observational study investing the incidence of d-ICH at
Sundsvall Regional Hospital. Data was collected from 2018-01-01 - 2020-05-30, and all data
collection followed a predetermined protocol. Data was collected by two persons.
Starting from the hospital's radiology registry, all CT-scan referrals from emergency
departments surgical section and acute surgical ward with a possible traumatic brain injury
was read. Hereafter patients' journals were used to retrieve mechanism of injury, pre-injury
medications, and arrival status.
TBI are typically classified after level of consciousness, internationally often measures in
Glasgow Coma Scale (GCS) (3). At Sundsvall Regional Hospital, RLS (Reaction Level Scale) is
more commonly used, hence it was used in data collection. However, in most cases patients'
mental status was only commented as "unaffected" without any use of neither GCS nor RLS. In
statistical analysis, we only recorded RLS where it was in clear print and choose not to
translate "unaffected" into RLS 1. RLS 1 and GCS 15 are comparable, and GCS 14 and RLS2 are
also comparable. mTBI is classified by Scandinavian Neurotrauma Committee's guidelines as a
GCS 14 after head trauma, or GCS 15 after head trauma in combination with loss of
consciousness, repeated vomiting, posttraumatic seizures, focal neurological deficits, signs
of skull fracture, intracranial shunts, antithrombotic treatment, or antiplatelet treatment
in combination with age over 65.
Inclusion criteria was mTBI and pre-injury anticoagulation or SGA therapy. In the initial
data collection, all patients with mTBI regardless of antitrombotic therapy status were
included for comparison for another study. Exclusion criteria was high energy trauma, age <18
years, concealed journals, spontaneous hemorrhage, RLS ≥3 (Figure 1). Due to the lack of
control CT, patients on solely ASA or LMWH was also excluded due to former local clinical
guidelines.
High energy trauma was excluded from this study, due to the heterogenous variety of injuries
and often multiple organ injuries. High energy trauma was defined as any traffic accident or
fall > 3 meters, or other traumas that required acute trauma care at the emergency trauma
room.
tICH was subcategorized into subdural hemorrhage (SDH), subarachnoid hemorrhage (SAH),
epidural hemorrhage or others. Age and gender were collected as demographic data. Severity of
head trauma, treatment with anticoagulation therapy (DOAC/VKA/LMWH/other) and/or antiplatelet
therapy (ASA/Clopidogrel/Ticagrelor/other) were noted. Antithrombotic therapy was used as an
overall term compromising both anticoagulation and antiplatelet treatment. The predominant
SGA used for single therapy in Sweden is Clopidogrel, and no participants in this study had
single therapy with Ticagrelor. SGA is therefore synonymous with Clopidogrel in this study.
Unclear formulations, positive findings or uncertain findings in the initial radiology
assessment was held to a second opinion by an experienced neuroradiologist. A total of 3
cases (1,2 %) were held to a second opinion assessment (Table 1).
Statistics Statistical analysis was executed using Microsoft Excel® version 2108 for
Microsoft Windows®. Demographic data were presented as means and standard deviations (SD), or
as counts and percentage where appropriate.
The sample size was set to a period of 29 months from January 2018 to May 2020, by which we
estimated by the study supervisors to match comparable studies in the field, thus no power
calculation prior to study start was done.
