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Completed
NCT05609734
No Cases of Delayed Intracranial Hemorrhage (d-ICH) Among Patients With Mild Traumatic Brain Injury (mTBI) on Oral Anticoagulation Therapy
Conditions: Traumatic Intracranial Hemorrhage, Traumatic Brain Injury
Sex: All
Ages: 18 Years – N/A
Enrollment: 249
Sponsor: Umeå University
Location: Sweden
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.
Eligibility Criteria
Inclusion Criteria: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: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.
Source: ClinicalTrials.gov (NCT05609734). StuddyBuddy aggregates publicly available trial information.