Heparin and the Reduction of Thrombosis (HART) Trial
Heparin and Catheter-related Thrombosis in Neonates and Infants Following Cardiac Surgery
調査の概要
詳細な説明
Patients are contacted pre-operatively and their parents consented. The following criteria apply:
Inclusion criteria:
All infants < 1 year of age undergoing cardiac surgery at Lucile Packard Children's Hospital
Exclusion Criteria:
Known coagulopathy History of clinically significant bleeding (GI, cranial, pulmonary) Need for therapeutic heparinization ECMO
Randomization and blinding are performed in the Pharmacy. The intervention is initiated at the intensive care unit physician's discretion, generally within the 1st 24 hours post-operatively. The study is terminated when all catheters have been discontinued or at POD #14, whichever occurs first.
Thrombosis is demonstrated by echocardiogram or ultrasound performed at
1 - 3 days, 5 - 7 days, and 10 - 14 days after initiation of the study drug.
The following are calculations for statistical analysis:
Sample size determination - Using 2 - sided alpha = 0.05 and Beta = 0.2, and assuming a baseline thrombosis incidence of 20%, 160 patients are required to detect an effect size of 15%.
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
-
-
California
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Stanford、California、アメリカ、94305
- Stanford University School of Medicine
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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:
- All infants < 1 year of age undergoing cardiac surgery at Lucile Packard Children's Hospital & #xA
Exclusion Criteria:
- Known coagulopathy
- History of clinically significant bleeding (GI, cranial, pulmonary)
- Need for therapeutic heparinization
- ECMO
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Study drug
Heparin sulfate infusion at 10 units/kg/hour
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Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery
他の名前：
|
|
プラセボコンパレーター：Placebo
Placebo - normal saline infusion
|
Infusion of normal saline
|
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 |
|---|---|---|
|
Thrombosis
時間枠：While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first). Echoes were performed after 24-48 hours and then every 3-5 days
|
Echocardiographic evidence of thrombosis while on study drug
|
While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first). Echoes were performed after 24-48 hours and then every 3-5 days
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Total PRBCs Transfused
時間枠：While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
|
While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
|
|
Days to Extubation
時間枠：While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
|
While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
|
|
Cardiac ICU Length of Stay
時間枠：While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
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While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
|
|
Need for Antibiotics
時間枠：While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
|
While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Stephen J. Roth M.D., M.P.H.、Stanford University
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
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。