No Cases of Delayed Intracranial Hemorrhage (d-ICH) Among Patients With Mild Traumatic Brain Injury (mTBI) on Oral Anticoagulation Therapy

NCT ID: NCT05609734

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 249 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-04-15

Brief 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.

Detailed 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.

Conditions

Traumatic Intracranial Hemorrhage; Traumatic Brain Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients with an delayed traumatic intracranial hemorrhage

A total of 249 control CTs was performed, where the initial CT was normal regarding tICH. In the initial assessments 1 case of d-ICH (0,41%) was found, but after second opinion this case (case 1, Table 1) was regarded as a pictorial artefact (Table 1). Hence, no d-ICH was found.

no intervention, only observational retrospective study

Intervention Type: OTHER

no intervention, only observational retrospective study

Patients without an delayed traumatic intracranial hemorrhage

A total of 249 control CTs was performed, where the initial CT was normal regarding tICH. In the initial assessments 1 case of d-ICH (0,41%) was found, but after second opinion this case (case 1, Table 1) was regarded as a pictorial artefact (Table 1). Hence, no d-ICH was found.

no intervention, only observational retrospective study

Intervention Type: OTHER

no intervention, only observational retrospective study

Interventions

no intervention, only observational retrospective study

no intervention, only observational retrospective study

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Umeå University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yücel Cengiz, Ph.D. M.D.

Role: STUDY_DIRECTOR

Umea University

Locations

Sundsvall Hospital

Sundsvall, , Sweden

Countries

Sweden

Other Identifiers

20HSN3790 nr2

Identifier Type: -

Identifier Source: org_study_id