Fibrinolysis Compared to Thoracoscopy for Pleural Infection
Fibrinolytic Therapy Versus Medical Thoracoscopy for Treatment of Pleural Infection: A Randomized Clinical Trial
調査の概要
詳細な説明
Background: Pleural infection (empyema or complex parapneumonic effusion (CPPE)) represents one of the most common clinical diagnoses encountered in clinical practice in the United States (US) It is associated with substantial morbidity and mortality despite advances in medical diagnostic and therapeutic strategies.
Objective: Compare two standard of care treatments: TPA/DNase vs early medical Thoracoscopy
Methods: We will conduct a prospective randomized clinical trial. We plan to enroll a total of 80 patients and randomize them to either Medical Thoracoscopy group or Fibrinolytic Therapy group.
Follow-up will be daily until hospital discharge and at 6 and 12 weeks in the outpatient setting
Primary Outcome: Duration of hospital stay after intervention
Secondary Outcome: Failure rate of assigned treatment and adverse events
Potential Outcome and Benefit: Determine best strategy for treating patients with pleural infection
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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Massachusetts
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Boston、Massachusetts、アメリカ、02215
- Beth Israel Deaconess Medical Center
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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:
- Subjects >18 years old with:
- Evidence of empyema or complex parapneumonic effusion
Exclusion Criteria:
- Age <18 years
- Pregnancy
- Inability to give informed written consent
- Previous thoracic surgery or thrombolytic therapy for pleural infection
- Medical thoracoscopy cannot be performed within 48 hours
- Hemodynamic instability or severe hypoxemia
- Non corrected coagulopathy
- Homogeneously echogenic effusion on pleural ultrasonography
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：Thoracoscopy group
Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.
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Medical thoracoscopy will be performed as per standard protocols.
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アクティブコンパレータ：Fibrinolytic group
Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase)
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Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg).
Therapy will be given twice daily for a maximum of 6 doses
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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 |
|---|---|---|
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Duration of hospital stay after intervention
時間枠：12 week follow up period
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Number of days hospitalized
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12 week follow up period
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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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Number of days with chest drainage
時間枠：12 week follow up period
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Number of days with chest drainage
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12 week follow up period
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Total length of hospital stay
時間枠：12 week follow up period
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Total days spent in the hospital
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12 week follow up period
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Failure rate of assigned treatment necessitating intervention
時間枠：12 week follow up period
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defined as any of the following:
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12 week follow up period
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Adverse events
時間枠：12 week follow up period
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Any adverse event (pain or bleeding)
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12 week follow up period
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In hospital and 30-day mortality
時間枠：30 days
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Death of a patient while being hospitalized or up to 30 days after
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30 days
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Change in pleural fluid volume on Chest CT scan prior to randomization (day 0) to prior to chest tube removal measured by radiologist blinded to treatment allocation using image J software
時間枠：12 week follow up period
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Pleural fluid volume measured with CT scan
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12 week follow up period
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Inflammatory biomarker (CRP) from randomization (day 0), at 6 weeks and 12 weeks respectively
時間枠：at randomization and at 6 and12 week follow up visit
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Inflammatory biomarker measure
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at randomization and at 6 and12 week follow up visit
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Total costs of each treatment modality
時間枠：6 and 12 week follow up period
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Total cost of each of treatment modality
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6 and 12 week follow up period
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協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
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 (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。
Medical Thoracoscopyの臨床試験
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Soterix MedicalGeorgetown University; National Institute of Neurological Disorders and Stroke (NINDS); University... と他の協力者完了
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