Hip Fracture Study of GSK576428 (Fondaparinux Sodium)
2018年8月30日 更新者:GlaxoSmithKline
Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism After Hip Fracture Surgery
This study is requested by PMDA to confirm the efficacy and the safety for HFS.
調査の概要
研究の種類
介入
入学 (実際)
48
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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-
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- GSK Investigational Site
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
20年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Patients undergoing hip fracture surgery within 10 days following the time of fracture of the hip (proximal femur) (or following the time of fracture estimated from trauma).
Exclusion Criteria:
- Active, clinically significant bleeding (excluding drainage).
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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:防止
- 割り当て:非ランダム化
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
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 |
---|---|---|
Rate of Major Bleeding During Treatment Period
時間枠:From the first study drug injection up to Day 17
|
Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100.
Signs and symptoms suggestive of venous thromboembolic events (VTE) included, but were not limited to lower extremity deep vein thrombosis (DVT): erythema, warmth, pain, swelling, tenderness and pulmonary embolism (PE): pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia.
Intended treatment period started 24±2 hours after surgical closure.
Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17).
These events were adjudicated by the Central Independent Adjudication Committee of Efficacy (CIACE).
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From the first study drug injection up to Day 17
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Rate of PE During Treatment Period
時間枠:Up to Day 17
|
Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100.
Signs and symptoms suggestive of VTE included, but were not limited to lower extremity PE: pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia.
Intended treatment period started 24±2 hours after surgical closure.
Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17).
These events were adjudicated by the CIACE.
It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.
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Up to Day 17
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Rate of DVT During Treatment Period
時間枠:Up to Day 17
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Rate (%) was defined as number of events divided by the number of patients evaluated multiplied by 100.
Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness.
Intended treatment period started 24±2 hours after surgical closure.
Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17).
These events were adjudicated by the CIACE.
It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.
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Up to Day 17
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Rate of Proximal DVT During Treatment Period
時間枠:Up to Day 17
|
Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100.
Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness.
Intended treatment period started 24±2 hours after surgical closure.
Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17).
These events were adjudicated by the CIACE.
It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.
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Up to Day 17
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Rate of Distal Only DVT During Treatment Period
時間枠:Up to Day 17
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Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100.
Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness.
Intended treatment period started 24±2 hours after surgical closure.
Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17).
These events were adjudicated by the CIACE.
It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.
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Up to Day 17
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Number of Participants With Major Bleeding During Treatment Period
時間枠:From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
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Major bleeding events were defined as clinically unusual bleeding meeting any of the following criteria: fatal bleeding, bleeding including retroperitoneal and intracranial bleeding or bleeding into a critical organ (eye, adrenal gland, pericardium, spine), reoperation due to bleeding/hematoma at the operative site, bleeding leading to a hemoglobin (Hb) fall >=2 grams per deciliter (g/dL, 1.6 millimoles per liter [mmol/L]) within 48 hour of the bleed, bleeding that required a transfusion of red blood cell or whole blood derived from >=900 millilters (mL) of whole blood within 48 hours of the bleed (excluding the autologous transfusion except for the treatment of bleeding adverse event (AE) and bleeding leading to the bleeding index (BI) >=2.
Major bleeding events were adjudicated by the Central Independent Adjudication Committee of Safety (CIACS).
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From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
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Number of Participants With Minor Bleeding and Any Bleeding (Major and/or Minor Bleeding)
時間枠:From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
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Minor bleeding and any bleeding (major and/or minor bleeding) events were adjudicated by the CIACS.
Minor bleeding was defined as clinically overt bleeding not meeting the criteria for major bleeding and considered more than expected in the clinical context.
Any bleeding (major and/or minor bleeding) could be recorded may be major and/or minor.
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From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
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Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death
時間枠:From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
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An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use.
The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
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From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
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Number of Transfused Participants
時間枠:From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
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Blood product transfusions consisted of packed red blood cells or fresh frozen plasma or both.
This was done between Day 2 and 2 calendar days after the last injection.
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From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
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Summary of Units Transfused
時間枠:From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
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Blood product transfusions consisted of packed red blood cells or fresh frozen plasma or both.
This was done between Day 2 and 2 calendar days after the last injection.
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From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
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Rate of Symptomatic DVT
時間枠:Up to Day 17
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Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100.
Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness.
Intended treatment period started 24±2 hours after surgical closure.
Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17).
These events were adjudicated by the CIACE.
It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.
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Up to Day 17
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2006年2月16日
一次修了 (実際)
2006年10月26日
研究の完了 (実際)
2006年10月26日
試験登録日
最初に提出
2006年5月1日
QC基準を満たした最初の提出物
2006年5月1日
最初の投稿 (見積もり)
2006年5月3日
学習記録の更新
投稿された最後の更新 (実際)
2018年9月4日
QC基準を満たした最後の更新が送信されました
2018年8月30日
最終確認日
2018年8月1日
詳しくは
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