Pradaxa (Dabigatran Etexilate) 150 mg/q.d. in Patients With Moderate Renal Impairment After Hip or Knee Replacement Surgery
Observational Cohort Study to Evaluate Safety and Efficacy of Pradaxa (Dabigatran Etexilate) in Patients With Moderate Renal Impairment (Creatinine Clearance 30-50 ml/Min) Undergoing Elective Total Hip Replacement Surgery or Total Knee Replacement Surgery
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Basildon、イギリス
- 1160.84.04405 Boehringer Ingelheim Investigational Site
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Bedford、イギリス
- 1160.84.04408 Boehringer Ingelheim Investigational Site
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Luton、イギリス
- 1160.84.04403 Boehringer Ingelheim Investigational Site
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Wigan、イギリス
- 1160.84.04401 Boehringer Ingelheim Investigational Site
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Yeovil、イギリス
- 1160.84.04407 Boehringer Ingelheim Investigational Site
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Latina、イタリア
- 1160.84.03908 Boehringer Ingelheim Investigational Site
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Milano、イタリア
- 1160.84.03902 Boehringer Ingelheim Investigational Site
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Monza、イタリア
- 1160.84.03904 Boehringer Ingelheim Investigational Site
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Udine、イタリア
- 1160.84.03909 Boehringer Ingelheim Investigational Site
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Wien、オーストリア
- 1160.84.4301 Boehringer Ingelheim Investigational Site
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Wien、オーストリア
- 1160.84.4310 Boehringer Ingelheim Investigational Site
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Kungälv、スウェーデン
- 1160.84.4603 Boehringer Ingelheim Investigational Site
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Motala、スウェーデン
- 1160.84.4601 Boehringer Ingelheim Investigational Site
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Sollefteå、スウェーデン
- 1160.84.4604 Boehringer Ingelheim Investigational Site
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Badalona (Barcelona)、スペイン
- 1160.84.3409 Boehringer Ingelheim Investigational Site
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Barcelona、スペイン
- 1160.84.3410 Boehringer Ingelheim Investigational Site
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Madrid、スペイン
- 1160.84.3403 Boehringer Ingelheim Investigational Site
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Malaga、スペイン
- 1160.84.3405 Boehringer Ingelheim Investigational Site
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Pamplona、スペイン
- 1160.84.3404 Boehringer Ingelheim Investigational Site
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Pozuelo de Alarcón - Madrid、スペイン
- 1160.84.3412 Boehringer Ingelheim Investigational Site
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Valencia、スペイン
- 1160.84.3401 Boehringer Ingelheim Investigational Site
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Zaragoza、スペイン
- 1160.84.3402 Boehringer Ingelheim Investigational Site
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Berlin、ドイツ
- 1160.84.04903 Boehringer Ingelheim Investigational Site
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Erlangen、ドイツ
- 1160.84.04947 Boehringer Ingelheim Investigational Site
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Gelnhausen、ドイツ
- 1160.84.4922 Boehringer Ingelheim Investigational Site
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Hachenburg、ドイツ
- 1160.84.04927 Boehringer Ingelheim Investigational Site
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Koblenz、ドイツ
- 1160.84.04929 Boehringer Ingelheim Investigational Site
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Marburg、ドイツ
- 1160.84.04902 Boehringer Ingelheim Investigational Site
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München、ドイツ
- 1160.84.04946 Boehringer Ingelheim Investigational Site
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Olsberg、ドイツ
- 1160.84.04913 Boehringer Ingelheim Investigational Site
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Sylt、ドイツ
- 1160.84.04914 Boehringer Ingelheim Investigational Site
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Wismar、ドイツ
- 1160.84.04938 Boehringer Ingelheim Investigational Site
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Würzburg、ドイツ
- 1160.84.04948 Boehringer Ingelheim Investigational Site
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Angers、フランス
- 1160.84.3311 Boehringer Ingelheim Investigational Site
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Bordeaux、フランス
- 1160.84.3334 Boehringer Ingelheim Investigational Site
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Caen Cedex 5、フランス
- 1160.84.3303 Boehringer Ingelheim Investigational Site
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Clermont-Ferrand cedex 1、フランス
- 1160.84.3314 Boehringer Ingelheim Investigational Site
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Creteil、フランス
- 1160.84.3320 Boehringer Ingelheim Investigational Site
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DIJON Cédex、フランス
- 1160.84.3307 Boehringer Ingelheim Investigational Site
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Illkirch、フランス
- 1160.84.3310 Boehringer Ingelheim Investigational Site
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Le Havre、フランス
- 1160.84.3335 Boehringer Ingelheim Investigational Site
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Les Lilas、フランス
- 1160.84.3326 Boehringer Ingelheim Investigational Site
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Lyon、フランス
- 1160.84.3312 Boehringer Ingelheim Investigational Site
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Marseille、フランス
- 1160.84.3305 Boehringer Ingelheim Investigational Site
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Nantes Cédex 2、フランス
- 1160.84.3323 Boehringer Ingelheim Investigational Site
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Paris、フランス
- 1160.84.3302 Boehringer Ingelheim Investigational Site
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Paris、フランス
- 1160.84.3306 Boehringer Ingelheim Investigational Site
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Pierre Bénite cedex、フランス
- 1160.84.3313 Boehringer Ingelheim Investigational Site
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Poitiers Cédex、フランス
- 1160.84.3324 Boehringer Ingelheim Investigational Site
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Saint Etienne Cédex 2、フランス
- 1160.84.3322 Boehringer Ingelheim Investigational Site
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Saint Saulve、フランス
- 1160.84.3319 Boehringer Ingelheim Investigational Site
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Toulouse Cédex 9、フランス
- 1160.84.3316 Boehringer Ingelheim Investigational Site
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Vannes Cédex、フランス
- 1160.84.3332 Boehringer Ingelheim Investigational Site
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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
サンプリング方法
調査対象母集団
説明
Inclusion criteria:
Patients of 18 years of age or above with moderate renal impairment (creatinine clearance 30-50 ml/min) undergoing elective total hip replacement surgery who consent in writing to their participation in this observational study
Exclusion criteria:
All patients who should not be treated with Pradaxa 150 mg according to the European Summary of Product Characteristics (SPC):
severe renal impairment (creatinine clearance < 30 ml/min); elevated liver enzymes > 2 upper limit of normal (ULN); Hepatic impairment or liver disease expected to have any impact on survival, anaesthesia with post-operative indwelling epidural catheters, hypersensitivity to dabigatran etexilate or to any of the excipients, active clinically significant bleeding, organic lesion at risk of bleeding, spontaneous or pharmacological impairment of haemostasis, concomitant treatment with quinidine, protehetic heart valve requiring anticoagulant treatment
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 |
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Renal Impairment
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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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Percentage of Patients With Major Bleeding Events (MBE)
時間枠:From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
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Major bleeding events were defined according to the modified McMaster criteria, and were classified by the investigator as Major bleeding event or Any bleeding event.
The criteria for MBE's were: fatal; clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected; clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation
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From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
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Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All Cause Mortality
時間枠:From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
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The co-primary efficacy variable sVTE was defined as the composite of documented symptomatic proximal and distal deep vein thrombosis (DVT) and documented symptomatic non-fatal pulmonary embolism (PE) and All Cause Mortality.
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From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
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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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Documented Symptomatic Proximal DVT, Documented Symptomatic Distal DVT, Documented Symptomatic Nonfatal Pulmonary Embolism and All-cause Mortality
時間枠:From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
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Percentage of participant with documented symptomatic proximal DVT (deep vein thrombosis), documented symptomatic distal DVT, documented symptomatic nonfatal pulmonary embolism and all-cause mortality
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From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
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Percentage of Patients With Major Extra-surgical Site Bleedings
時間枠:From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
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Percentage of Patients With Major Extra-surgical Site Bleedings
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From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
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Volume of Wound Drainage (Post-operative)
時間枠:From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
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Volume of Wound Drainage after surgery
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From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
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協力者と研究者
スポンサー
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。