Acute Normovolemic Hemodilution on ROTEM in Cardiac Surgery
Impact of Acute Normovolemic Hemodilution on Whole Blood Coagulation Profile During Post-cardiopulmonary Bypass in Cardiac Surgery: Rotational Thromboelastometry Study
Impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well established.
Patients undergoing cardiac surgery employing moderate hypothermic CPB (n=40) are randomly allocated into one of two groups: in Group-ANH(n=20), ANH is applied by using a balanced hydroxyethyl starch (HES 130/0.6); and in Group-C, ANH is not applied.
After weaning from CPB, intergroup differences of INTEM, EXTEM, FIBTEM and APTEM profiles are analyzed.
As a primary outcome, inter-group difference between maxiaml clot firmness of EXTEM will be determined at 10 min after ANH in Group-ANH and that at control.
調査の概要
状態
詳細な説明
Background: Impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well established.
Method: Patients undergoing cardiac surgery employing moderate hypothermic CPB (n=40) are randomly allocated into one of two groups: in Group-ANH(n=20), ANH is applied by using a balanced hydroxyethyl starch (HES 130/0.6); and in Group-C ANH is not applied.
Intergroup differences of INTEM, EXTEM, FIBTEM and APTEM profiles are analyzed. after anesthesia induction (control) and after weaning form CPB and protamine neutralization (after-CPB) in both groups. In Group-ANH, those are determined after ANH (after-ANH).
As a primary outcome, inter-group difference between maxiaml clot firmness of EXTEM is determined at 10 min after ANH in Group-ANH and that at control.
As secondary outcomes, intergroup differences of Hematocrit (Hct), Na+, K+, HCO3-, Ca2+, osmolarity, s-Cr are determined Intergroup difference of data at T2 are performed.
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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-
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Seoul、大韓民国、143-729
- Konkuk University 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:
- patients undergoing cardiac surgery with cardiopulmonary bypass who signed written informed consent
Exclusion Criteria:
- preoperative renal failure requiring reran replacement therapy
- preoperative liver disease
- preoperative low cardiac output (EF < 50%)
- Preoperative IABP application, Atrial fibrillation, Pacemaker,
- contraindication for applying TEE
- intraoperative withdrawal
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：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：Control group
patients undergoing cardiac surgery supposed not to get aucte normovolemic hemodilution (ANH) before CPB
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|
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アクティブコンパレータ：Acute normovolemic hemodilution group
patients undergoing cardiac surgery supposed to get aucte normovolemic hemodilution (ANH) before CPB
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applying acute normovolemic hemodilution (ANH) by using HES 130/0.4 of 5 ml/kg before the initiation of cardiopulmonary bypass
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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 |
|---|---|---|
|
Maximal clot firmness of EXTEM
時間枠：10 min after completion of acute normovolemic hemodilution (ANH)
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Maxiaml clot firmess (MCF) of EXTEM of rotational thromboleastometry
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10 min after completion of acute normovolemic hemodilution (ANH)
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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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Clot formation time of EXTEM
時間枠：10 min after completion of acute normovolemic hemodilution
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Clot formation time of EXTEM of rotational thromboleastometry
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10 min after completion of acute normovolemic hemodilution
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A10 of FIBTEM
時間枠：10 min after completion of acute normovolemic hemodilution
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A10 of FIBTEM of rotational thromboelastometry
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10 min after completion of acute normovolemic hemodilution
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協力者と研究者
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
本研究に関する用語
キーワード
その他の研究ID番号
- KUH1160030
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。
ヒドロキシエチルスターチ (HES 130/0.6)の臨床試験
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Konkuk University Medical Center完了
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St. Boniface HospitalUniversity of Manitobaわからない
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Chung-Ang University Hosptial, Chung-Ang University...わからない
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Paraskevi Matsota完了