Viscoelastic Tests-Guided Therapy In Liver Transplantation (VETLT)
Association Between Viscoelastic Tests-Guided Therapy With Synthetic Factor Concentrates And Allogenic Blood Transfusion In Liver Transplantation: A Before-After Study
BACKGROUND: Perioperative bleeding and transfusion are important causes of morbidity and mortality in patients undergoing liver transplantation. The aim of this study is to assess whether viscoelastic tests-guided therapy with the use of synthetic factor concentrates impact transfusion rates of hemocomponents in adult patients undergoing liver transplantation.
METHODS: This is an interventional before-after comparative study. Patients undergoing liver transplantation before the implementation of a protocol using thromboelastometry and synthetic factor concentrates were compared to patients after the implementation. Primary outcome was transfusion of any hemocomponents. Secondary outcomes included: transfusion of red blood cells (RBC), fresh frozen plasma (FFP), cryoprecipitate or platelets, clinical complications, length of stay and in-hospital mortality.
調査の概要
状態
研究の種類
入学 (実際)
段階
- 適用できない
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:
- Deceased Donor Liver Transplantation
- Chronic Liver Disease
Exclusion Criteria:
- Acute Liver Failure
- Combined Transplantation
- Re-Transplantation is Less Than 30 Days After the First Transplant
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:非ランダム化
- 介入モデル:順次割り当て
- 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 |
---|---|
アクティブコンパレータ:Usual Care (Before)
No Thromboelastometry No Synthetic Factor Concentrates Usual Care
|
Treatment of Coagulation Disorders Using Standard Coagulation Tests and Blood Components
|
実験的:Thromboelastometry-Guided Therapy (After)
Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates
|
Thromboelastometry-Guided Treatment of Coagulation Disorders Using Synthetic Factor Concentrates
|
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 |
---|---|---|
Need of Any Blood Products Transfusion
時間枠:48 Hours
|
Collapsed composite of need of any transfusion of blood product during surgery and in the first 48 hours in the postoperative, including the need of RBC, FFP, cryoprecipitate and/or platelets.
|
48 Hours
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Use of Synthetic Factor Concentrates or Antifibrinolytic
時間枠:48 Hours
|
Any use of synthetic factor concentrates or antifibrinolytic
|
48 Hours
|
Clinical Complications Related to the Procedure
時間枠:Third days or until hospital discharge, whichever occurs first
|
Defined as: 1) Upper digestive hemorrhage; 2) Arterial thrombosis; 3) Infection; and/or 4) Any thromboembolic event
|
Third days or until hospital discharge, whichever occurs first
|
Duration of Mechanical Ventilation
時間枠:Third days or until hospital discharge, whichever occurs first
|
Duration of mechanical ventilation in the post-operative period
|
Third days or until hospital discharge, whichever occurs first
|
ICU Length of Stay
時間枠:Third days or until ICU discharge, whichever occurs first
|
Duration of stay in the intensive care unit
|
Third days or until ICU discharge, whichever occurs first
|
Hospital Length of Stay
時間枠:Third days or until hospital discharge, whichever occurs first
|
Duration of stay in the hospital
|
Third days or until hospital discharge, whichever occurs first
|
In-Hospital Mortality
時間枠:Third days or until hospital discharge, whichever occurs first
|
Any death during hospitalization
|
Third days or until hospital discharge, whichever occurs first
|
協力者と研究者
捜査官
- 主任研究者:Ary Serpa Neto, MD, MSc, PhD、Physician and Researcher
- スタディディレクター:Raffael PC Zamper, MD、Raffael
出版物と役立つリンク
一般刊行物
- Rana A, Petrowsky H, Hong JC, Agopian VG, Kaldas FM, Farmer D, Yersiz H, Hiatt JR, Busuttil RW. Blood transfusion requirement during liver transplantation is an important risk factor for mortality. J Am Coll Surg. 2013 May;216(5):902-7. doi: 10.1016/j.jamcollsurg.2012.12.047. Epub 2013 Mar 9.
- Weber CF, Gorlinger K, Meininger D, Herrmann E, Bingold T, Moritz A, Cohn LH, Zacharowski K. Point-of-care testing: a prospective, randomized clinical trial of efficacy in coagulopathic cardiac surgery patients. Anesthesiology. 2012 Sep;117(3):531-47. doi: 10.1097/ALN.0b013e318264c644.
- Luddington RJ. Thrombelastography/thromboelastometry. Clin Lab Haematol. 2005 Apr;27(2):81-90. doi: 10.1111/j.1365-2257.2005.00681.x.
- Hartmann M, Szalai C, Saner FH. Hemostasis in liver transplantation: Pathophysiology, monitoring, and treatment. World J Gastroenterol. 2016 Jan 28;22(4):1541-50. doi: 10.3748/wjg.v22.i4.1541.
- Wang SC, Shieh JF, Chang KY, Chu YC, Liu CS, Loong CC, Chan KH, Mandell S, Tsou MY. Thromboelastography-guided transfusion decreases intraoperative blood transfusion during orthotopic liver transplantation: randomized clinical trial. Transplant Proc. 2010 Sep;42(7):2590-3. doi: 10.1016/j.transproceed.2010.05.144.
- Zamper RPC, Amorim TC, Queiroz VNF, Lira JDO, Costa LGV, Takaoka F, Juffermans NP, Neto AS. Association between viscoelastic tests-guided therapy with synthetic factor concentrates and allogenic blood transfusion in liver transplantation: a before-after study. BMC Anesthesiol. 2018 Dec 22;18(1):198. doi: 10.1186/s12871-018-0664-8.
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 (実際)
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。
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