No Cases of Delayed Intracranial Hemorrhage (d-ICH) Among Patients With Mild Traumatic Brain Injury (mTBI) on Oral Anticoagulation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 249
- 试验地点
- 1
- 主要终点
- delayed traumatic intracranial hemorrhage
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
delayed traumatic intracranial hemorrhage
时间窗: 6 hours
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.
次要结局
未报告次要终点
