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

NCT05609734 | Completed

• 1 other identifier: 20HSN3790 nr2
• Study Type: observational
• Target: 249
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Intracranial Hemorrhage; Traumatic Brain Injury

Keywords

antithrombotic therapy

Outcome Measures

Primary Outcomes (1)

• delayed traumatic intracranial hemorrhage

  Inclusion criteria was mTBI and pre-injury anticoagulation or SGA therapy. A secondary CT scan was performed 6 hours later, to detect a delayed intracranial hemorrhage.

  6 hours

Study Arms (2)

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.

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.

Other: no intervention, only observational retrospective study

Interventions

no intervention, only observational retrospective study OTHER

no intervention, only observational retrospective study

Patients with an delayed traumatic intracranial hemorrhage; Patients without an delayed traumatic intracranial hemorrhage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Sundsvall Hospital

Sundsvall, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

CT scans, patient journals and bloodsample results, no bloodsamples were saved for further analysizes

MeSH Terms

Conditions

Intracranial Hemorrhage, Traumatic; Brain Injuries, Traumatic

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; Brain Injuries

Study Officials

• Yücel Cengiz, Ph.D. M.D.

  Umea University

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: November 8, 2022
• Study Start: January 1, 2021
• Primary Completion: March 30, 2021
• Study Completion: April 15, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)