Mild Traumatic Brain Injury and the Risk for Traumatic Intracranial Hemorrhage

NCT05609721 | Completed

• 1 other identifier: 20HSN3790
• Study Type: observational
• Target: 2,044
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Traumatic Intracranial Hemorrhage; Brain Injuries

Outcome Measures

Primary Outcomes (1)

• traumatic Intracranial hemorrhage

  In this retrospective study, all CT-scan referrals from surgical branch of the emergency department and acute surgical department, suspecting traumatic brain hemorrhage, were included. The studied period was between Jan 1st 2018 till May 30th 2020. Patients with an traumatic Intracranial hemorrhage were subcategorized into subdural, subarachnoid, epidural, and other.

  Jan 1st 2018 till May 30th 2020

Study Arms (2)

Patients with antithromotic therapy

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.

Other: no intervention, only observational study

Patients without antothrombotic therapy

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.

Other: no intervention, only observational study

Interventions

no intervention, only observational study OTHER

no intervention, only observational study

Patients with antithromotic therapy; Patients without antothrombotic therapy

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Patients that fulfilled following criteria were included (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.

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Sundsvall Hospital

Sundsvall, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

CT scan and bloodsample results, no bloodsamples were saved for further analysis

MeSH Terms

Conditions

Intracranial Hemorrhage, Traumatic; Brain Injuries

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: November 8, 2022
• Study Start: January 1, 2021
• Primary Completion: March 30, 2021
• Study Completion: June 20, 2021
• Last Updated: November 8, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)