虚血性脳卒中血栓回収術後のベッド頭部挙上（HoBIT） (HoBIT)
前循環大血管閉塞性脳卒中に対する血管内血栓回収術後の機能的回復に及ぼす、0度対30度以上のベッド頭側挙上体位の影響を評価する、実用的、多施設、適応的、前向き、非盲検、エンドポイント盲検化ランダム化臨床試験。
Endovascular thrombectomy (EVT), also known as clot retrieval, is a procedure that improves recovery for people who suffer a stroke by removing blood clots from large blood vessels in the brain. However, half of the patients undergoing EVT to remove the clot from a brain vessel still face lasting disabilities or even die within three months.
The investigators of the HoBIT trial are trying to find out if the position of the head of bed improves recovery in patients who undergo EVT after suffering from a stroke.
The purpose of this study is to establish the benefit of head of bed positioning at 0-degrees compared with 30-degrees or more after EVT for improving functional outcomes in adults that suffer from a stroke.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Samantha Block, BSc
- 電話番号：905-521-2100
- メール：hobit@phri.ca
研究連絡先のバックアップ
- 名前：Amanda Taylor, BSc
- 電話番号：905-521-2100
- メール：hobit@phri.ca
研究場所
-
-
Ontario
-
Greater Sudbury、Ontario、カナダ、P3E5J1
- 募集
- Health Sciences North
-
主任研究者：
- Aviraj Deshmukh, MD
-
コンタクト：
- Mythili Velma
- 電話番号：705-523-7100
- メール：mvelma@hsnri.ca
-
Hamilton、Ontario、カナダ、L8L 2X2
- 募集
- Hamilton General Hospital
-
主任研究者：
- Aristeidis Katsanos, MD
-
コンタクト：
- Kanchana Ratnayake
- 電話番号：905-521-2100
- メール：ratnayake@hhsc.ca
-
-
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
説明
Inclusion Criteria:
- Age 18 years or older on the date of randomization
- Endovascular thrombectomy (EVT) for large vessel occlusion (LVO) in the anterior circulation, according to current guidelines and local standards of clinical care. The definition of LVO may include the intracranial segment of the internal carotid artery (ICA), and/ or the M1 segment (proximal, mid, distal) of the middle cerebral artery (M1-MCA), and/ or the proximal M2 segment of the MCA (M2-MCA)
- Capable of giving signed informed consent either independently, or by a legally authorized representative (LAR), or via a deferred consent process approved by the relevant ethics committee, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion Criteria:
- Mechanical ventilatory support for acute medical condition prior to procedure (i.e. required for reasons other than procedure)
- Symptomatic congestive heart failure, chronic obstructive pulmonary disease, or any other medical condition that would make either HoB position inappropriate for patient care in the judgement of the investigator.
- Any condition, such as but not limited to, agitation/ delirium or severe nausea/ vomiting, that, in the view of the investigator, is expected to significantly impede maintaining the assigned HoB
- Any condition with life expectancy of less than 3 months
- Inability to randomize within 1 hour from the end of the EVT
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
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Intervention Arm
Head of bed position of 0-degrees |
Flat position with the HoB at 0° elevation for a continuous 24-hour period. Turning to the side (left or right) is permitted, as long as there is no head elevation.
他の名前：
|
|
他の：Control Arm
Head of bed position of 30-degrees or greater |
Semi-recumbent position with the HoB to at least 30 degrees for a continuous 24-hour period. Head and torso must remain elevated at 30 degrees or higher, using the hospital bed's positioning system.
他の名前：
|
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 |
|---|---|---|
|
Functional disability
時間枠：90±14 days from randomization
|
Functional disability assessed with the modified Rankin Scale (mRS) score. Scores: 0 - No symptoms
|
90±14 days from randomization
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Absolute difference in NIHSS score
時間枠：Between randomization and 36±12 hours from randomization
|
Absolute difference in the National Institutes of Health Stroke Scale (NIHSS) scores Scores: 0 - No stroke symptoms 1-4 - Minor stroke 5-15 - Moderate stroke 16-20 - Moderate to severe stroke 21-42 - Severe stroke |
Between randomization and 36±12 hours from randomization
|
|
Early neurological improvement
時間枠：36±12 hours from randomization, compared with randomization
|
Early neurological improvement, defined as an absolute decrease of the National Institutes of Health Stroke Scale (NIHSS) score by 4 points or more Scores: 0 - No stroke symptoms 1-4 - Minor stroke 5-15 - Moderate stroke 16-20 - Moderate to severe stroke 21-42 - Severe stroke |
36±12 hours from randomization, compared with randomization
|
|
Functional impairment
時間枠：Day 7 from randomization or discharge if happens first
|
Functional impairment assessed with the Modified Rankin Score (mRS) Scores: 0 - No symptoms
|
Day 7 from randomization or discharge if happens first
|
|
Functional independence
時間枠：Day 7 from randomization or discharge if happens first and 90±14 days from randomization
|
Functional independence defined as Modified Rankin Score (mRS) of 2 or less Scores: 0 - No symptoms
|
Day 7 from randomization or discharge if happens first and 90±14 days from randomization
|
|
Quality of life assessment
時間枠：90±14 days from randomization
|
Quality of life assessed with the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Scores range from 1 (full health) to 0 (dead), with negative values indicating states that are "worse than dead". |
90±14 days from randomization
|
|
Intervention adherence
時間枠：First 24 hours from randomization
|
Adherence to the assigned HoB position for 24 hours from randomization, defined as >80% of total time spent in the assigned HoB |
First 24 hours from randomization
|
|
Total time spent
時間枠：First 24 hours from randomization
|
Total time spent in the assigned HoB position |
First 24 hours from randomization
|
|
Infarct volume
時間枠：24 +/- 12 hours from randomization and 5-7 days from randomization
|
Infarct volume on the brain imaging (CT/ MRI) performed as part of standard clinical care |
24 +/- 12 hours from randomization and 5-7 days from randomization
|
協力者と研究者
捜査官
- 主任研究者：Aristeidis Katsanos, MD、Population Health Research Institute
- 主任研究者：Mike Sharma, MD、Population Health Research Institute
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。