「SCRIBBLE」脊髄損傷血液バイオマーカー縦断評価 (SCRIBBLE)
Prospective, single center study designed to assess blood biomarkers for classifying injury severity and predict neurologic recovery in traumatic spinal cord injured (SCI) patients.
Study will also establish the accuracy of point to care devices for SCI blood biomarkers and support the biospecimen collection for the International Spinal Cord Injury Biobank (ISCIB).
調査の概要
詳細な説明
This single center study at Vancouver General Hospital (VGH) will enroll patients with acute traumatic cervical and thoracic SCI who will have blood samples obtained daily for the first week post-injury. They will then have follow-up neurologic assessments at 6 and 12 months post-injury. The specific aims of the study are to:
- Validate serum Neurofilament Light Chain (NF-L) and Glial Fibrillary Acidic Protein (GFAP) as biomarkers of acute SCI for classifying injury severity and predicting neurologic recovery.
- Establish the relationship between serum and plasma levels of NF-L and GFAP.
- Establish the accuracy of point-of-care devices for measuring GFAP.
- Support biospecimen collection for the International Spinal Cord Injury Biobank (ISCIB).
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Allan Aludino
- 電話番号：61689 604-875-4111
- メール：allan.aludino@vch.ca
研究場所
-
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British Columbia
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Vancouver、British Columbia、カナダ、V5Z1M9
- 募集
- Vancouver General Hospital
-
コンタクト：
- Allan Aludino
- メール：allan.aludino@vch.ca
-
主任研究者：
- Brian Kwon
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
All participants for this study will be recruited at Vancouver General Hospital. The study will include two groups/cohorts:
SCI Subjects. Patients who suffer a traumatic spinal cord injury who meet the following inclusion criteria are eligible for admission into the study as "SCI subjects":
Non-SCI Spine Trauma Control Subjects. Patients who suffer a fracture or dislocation of their spinal column but without neurologic injury are eligible for admission into the study as "Non-SCI Spine Trauma Control Subjects" if they meet the following inclusion criteria:
説明
Inclusion Criteria
SCI Participants. Patients who suffer a traumatic spinal cord injury who meet the following inclusion criteria are eligible for admission into the study as "SCI participants":
- Male or Female ≥ 19 years of age
- Blunt (non-penetrating) traumatic spinal cord injury
- Baseline neurologic impairment deemed "complete"(AIS A) or "incomplete" (AIS B, C, D)
- Bony spinal level involvement between C0 and L1 inclusive
- Ability to have initial blood sample drawn within 24 hours of injury
- Have either an arterial line, central line, or intravenous line for collecting blood samples
- Able and willing to provide informed consent
Non-SCI Spine Trauma Control Participants. Patients who suffer a fracture or dislocation of their spinal column without neurologic injury who meet the following inclusion criteria are eligible for admission into the study as "Non-SCI Spine Trauma Control Participants":
- Male or Female ≥ 19 years of age
- Traumatic spinal fracture between C0 and L1 without spinal cord injury
- Collection of initial blood sample within 24 hours of injury
- Have either an arterial line, central line, or intravenous line for collecting blood samples
- Able and willing to provide informed consent
Exclusion Criteria
Patients who fulfill any of the following criteria are not eligible for admission into the study:
- Penetrating spinal cord injury (e.g. gunshot, stab)
- Spinal cord injury with sensory deficit only (i.e. no motor deficit)
- Spinal injury below L1
- Isolated radiculopathy without fracture
- Isolated cauda equina injury
- Pre-existing thromboembolic disease or coagulopathy (disorders related to blood clotting), such as haemophilia or von Willebrand's disease
- Have any other medical condition that in the investigator's opinion would render the study procedures dangerous or impair their ability to receive treatment
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
|---|
|
SCI Subjects
Patients who suffer a traumatic spinal cord injury who meet the following inclusion criteria are eligible for admission into the study as "SCI subjects": |
|
Non-SCI Spine Trauma Control Subjects.
Patients who suffer a fracture or dislocation of their spinal column but without neurologic injury are eligible for admission into the study as "Non-SCI Spine Trauma Control Subjects" |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Levels of specific biochemical markers in blood
時間枠：Day 1 - 7
|
Daily serum samples will be collected to assess serum GFAP and NF-L as biomarkers of acute SCI for classifying injury severity and predicting neurologic recovery |
Day 1 - 7
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination
時間枠：12 Months
|
Neurologic recovery over time will be measured using the ISNCSCI examination - at Baseline, Month 6 and Month 12. Our outcome measure will be the change in total motor score at 6 months post-injury. |
12 Months
|
協力者と研究者
捜査官
- 主任研究者：Brian Kwon, MD、University of British Columbia
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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