Cerebral Embolic Load in Patients Undergoing Surgical Aortic Valve Replacement: A Comparison of the Conventional With the Minimized Extracorporeal Circulation Technique Using Transcranial Doppler Ultrasound (AKE-MECC)
Aortic Valve Replacement Using Closed Extracorporeal Circuit. Minimized Versus Conventional Extracorporeal Circulation Technique: Qualitative Differences
調査の概要
状態
詳細な説明
Background
The gold standard to treat severe aortic valve stenosis is currently the surgical aortic valve replacement (SAVR) using conventional extracorporeal circulation (CECC). SAVR, however, can be performed also on minimized extracorporeal circulation (MECC), which is characterized by reduced priming volume and interfaces between blood and artificial surfaces and blood-air interface, respectively. Further technical developments of the MECC system together with reports on less induction of the coagulation cascade and activation of inflammatory systemic response may account for a reduced incidence of microbubble generation with MECC system.
Objective
The aim of the is to investigate the procedural-related incidence of high-intensity transient signals (HITS) representing solid or gaseous microembolism reaching the cerebral vessels.
Methods
Patients undergoing SAVR are included in the study and randomised to either MECC or CECC technique. HITS are continuously bilaterally detected during the entire intraoperative period by transcranial Doppler ultrasound.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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-
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Bern、スイス、3010
- University Hospital Bern
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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:
- Isolated Severe Aortic Valve Stenosis
- No other cardiac disease
- No other coronary heart disease
- Written informed consent
Exclusion Criteria
- Double valve surgery
- Concomitant coronary artery bypass surgery
- Vascular surgery
- Age < 18 yrs.
- Age > 80 yrs.
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Conventional Extracorporeal Circulation Technique
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This group of patients receives surgical aortic valve replacement using CECC.
|
|
実験的：Minimized Extracorporeal Circulation Technique
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This group of patients receives surgical aortic valve replacement using MECC.
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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 |
時間枠 |
|---|---|
|
Total and interval-related cerebral microembolic load as measured by transcranial Doppler
時間枠：Intraoperative period (start surgical procedure to skin suture, duration approx. 4 hrs)
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Intraoperative period (start surgical procedure to skin suture, duration approx. 4 hrs)
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Cerebral complications, e.g. delirium and stroke as detected clinically
時間枠：In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital period (until hospital discharge, duration approx. 7-10 days)
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Redo surgery
時間枠：In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital period (until hospital discharge, duration approx. 7-10 days)
|
|
ICU length of stay
時間枠：In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital period (until hospital discharge, duration approx. 7-10 days)
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Extubation time
時間枠：In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital period (until hospital discharge, duration approx. 7-10 days)
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Thromboembolic complications
時間枠：In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital infections
時間枠：In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital Mortality
時間枠：In-hospital period (until hospital discharge, duration approx. 7-10 days)
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In-hospital period (until hospital discharge, duration approx. 7-10 days)
|
協力者と研究者
捜査官
- 主任研究者：Thierry Carrel, MD, PhD、Department of Cardiovascular Surgery
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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。