Bedside Evaluation of Coagulation in Children With Congenital Heart Disease (POCHEMO)
"Point-Of-Care" Evaluation of Hemostasis in Children With Congenital Heart Disease
The purpose of this study is to assess coagulation and platelet function in children with congenital heart disease, measured with a bedside device (thromboelastometry and impedance aggregometry).
The investigators also aim to determine if this device detect post-cardiopulmonary bypass clotting derangements and may help to manage bleeding in this population.
調査の概要
詳細な説明
Hemostasis, a main concern during and after any surgical procedure, is traditionally monitored by the following laboratory tests: activated Partial Thrombin Time (aPTT), prothrombin time (PT), fibrinogen, platelets count. They neither provide a reliable estimate of the risk of bleeding, nor allow determining useful interventions.
New investigations of hemostasis are now used and validated during and after surgery: Rotational Thromboelastometry (ROTEM®) and impedance aggregometry. This is a quick bedside functional analysis of the patient's clotting. Children who undergo surgery under cardiopulmonary bypass (CPB) are particularly at risk of bleeding and this population hasn't been studied with large cohort yet.
Hypothesis: Hemostasis in children with CHD, especially when cyanotic, is intrinsically abnormal. The corrective surgery on CPB induces further hemostatic disorders which can be identified by the ROTEM platelet®.
The aim of the study is to evaluate the hemostatic function of the child with congenital heart disease using a Point-Of-Care (platelet-ROTEM ®) system, before surgery and after alterations induced by cardiopulmonary bypass (CPB).
This is a single center, observational, prospective study. Expected duration: 2 years. The investigators plan to include 200 patients with CHD, 100 patients undergoing surgery with CPB and 100 patients with congenital heart disease requiring cardiac catheterization. Recruitment will be conducted by the Division of Paediatric Cardiology.
Inclusion criteria include an age of 0-16 years and a diagnosis of congenital heart disease requiring surgery with CPB or cardiac catheterization. Patients with known dyscrasia or treated with antiaggregant within 10 days/oral anticoagulants within 48h before surgery/catheterization.
ROTEM platelet® test will be performed before surgery/catheterization. Patients undergoing surgery will have a second test within 30 minutes after the end of cardiopulmonary bypass. All patients will benefit from the usual cares.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Vaud
-
Lausanne、Vaud、スイス、1011
- PICU, Centre Hospitalier Universitaire Vaudois
-
-
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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- children between 0 and 16 years, born with a congenital heart disease requiring either cardiac catheterization or surgery with cardiopulmonary bypass
- parental and/or patient consent
Exclusion Criteria:
- known hemostatic disorder
- known platelet function disorder
- antiaggregation treatment <10 days before blood sampling
- oral anticoagulation <2 days before blood sampling
- intravenous heparin <6 hours before blood sampling
- patient and parents unable to consent
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
コホートと介入
グループ/コホート |
|---|
|
Cardiopulmonary bypass
Children with congenital heart defect undergoing surgery on cardiopulmonary bypass
|
|
cardiac catheterism
Children with congenital heart defect undergoing cardiac catheterism
|
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 |
|---|---|
|
Hemostasis measured by thromboelastometry and impedance aggregometry
時間枠：Single measurement, during general anesthesia, immediately before procedure, when arterial line available
|
Single measurement, during general anesthesia, immediately before procedure, when arterial line available
|
|
Hemostasis measured by thromboelastometry and impedance aggregometry in cyanotic children
時間枠：Single measurement, during general anesthesia, immediately before procedure, when arterial line available
|
Single measurement, during general anesthesia, immediately before procedure, when arterial line available
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Thromboelastometry and impedance aggregometry changes after cardiopulmonary bypass (CPB)
時間枠：maximum 3 measurements, during surgery and up to 6 hours after end of CBP
|
maximum 3 measurements, during surgery and up to 6 hours after end of CBP
|
|
Thromboelastometry and impedance aggregometry changes in children with significant bleeding after CPB
時間枠：Single measurement, during general anesthesia, immediately before procedure, when arterial line available
|
Single measurement, during general anesthesia, immediately before procedure, when arterial line available
|
協力者と研究者
捜査官
- 主任研究者：Stefano Di Bernardo, MD、CHUV
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 (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。