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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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05609734). StuddyBuddy aggregates publicly available trial information.