Cerebrospinal Fluid (CSF) Drainage Study
High Volume Cerebrospinal Fluid Diversion in the Management of Aneurysmal Subarachnoid Hemorrhage: A Pilot Study
When patients suffer a subarachnoid hemorrhage (bleeding around the brain), they often develop hydrocephalus. This is an enlargement of the fluid-filled spaces (ventricles) in the brain. Standard-of-care treatment includes placing an external ventricular drain (EVD) to drain off fluid. Eventually the EVD is weaned with the goal of removing it. Occasionally a patient does not tolerate this and a permanent surgery needs to be done to internalize a shunt.
Though this is done commonly and routinely throughout the world, there are no good studies to address how to optimally set the EVD level and how fast to wean it. Most set the EVD to a level of around 15 mmHg. The investigators hypothesize that setting the EVD lower (which will allow higher volume Cerebrospinal Fluid (CSF) drainage through the EVD) will improve perfusion at the level of the microcirculation in the brain, and result in improved neurologic outcomes.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Florida
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Jacksonville、Florida、アメリカ、32224
- Mayo Clinic in Florida
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Minnesota
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Rochester、Minnesota、アメリカ、55905
- Mayo Clinic in Rochester
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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
- Age ≥ 18 years
- Diagnosis of acute subarachnoid hemorrhage (SAH), confirmed with noncontrast head CT
- SAH is suspected to be aneurysmal in source
- Clinical management requires placement of EVD within 2 days of suspected time of hemorrhage
Exclusion Criteria
- Age < 18 years
- SAH of traumatic or non-aneurysmal etiology
- Patients treated with lumbar drains
- EVD placement ≥ 3 days after suspected time of hemorrhage
- Known contraindication to induction of relative intracranial hypotension (e.g. acute subdural hematoma)
- Pre-morbid mRS ≥ 3
- EVD that is suboptimally placed by CT obtained after EVD placement (i.e. EVD not in the ventricular system)
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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実験的：High volume CSF diversion
The EVD will be set to an initial level of 5 mmHg.
The drain will remain in place at a level of ≤ 5 mmHg until at least day 10 after SAH before a weaning trial is attempted.
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CSF drainage
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アクティブコンパレータ：Conventional CSF diversion
The EVD will be set to a level of 15 mmHg for as long as needed for the treatment of hydrocephalus, and subsequently weaned at the discretion of the treating physician.
Lowering the level of the EVD can be considered by the treating physician if sustained intracranial hypertension occurs
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CSF drainage
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Modified Rankin Scale
時間枠：90-days
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The primary outcome is clinical outcome at 90 days.
A favorable outcome is defined as a score of 1 or 2 on the modified Rankin Score (mRS) and poor outcome defined as a mRS of 3-6.
This assessment will be made by a clinician who was blinded to the patient's CSF diversion treatment arm.
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90-days
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Infarction
時間枠：90-days
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Presence of radiologic infarction
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90-days
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Vasospasm
時間枠：90-days
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Evidence of vasospams based upon TCD and/or angiography
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90-days
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Shunt placement
時間枠：90-days
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Rate of shunt placement
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90-days
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Ventriculitis
時間枠：90-days
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Rate of ventriculitis
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90-days
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Modified Rankin Scale
時間枠：Hospital discharge (average 3 weeks)
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Modified rankin Scale upon discharge from the hospital
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Hospital discharge (average 3 weeks)
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MMSE
時間枠：90-days
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Cognitive status evaluated using the MMSE
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90-days
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Length of ICU stay
時間枠：Average 3 weeks
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Evalute the average length of ICU stay for this patient population.
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Average 3 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Giuseppe Lanzino, MD、Mayo Clinic
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。