- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00320424
Hip Fracture Study of GSK576428 (Fondaparinux Sodium)
30. srpna 2018 aktualizováno: 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.
Přehled studie
Typ studie
Intervenční
Zápis (Aktuální)
48
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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- GSK Investigational Site
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
20 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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).
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Nerandomizované
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Rate of Major Bleeding During Treatment Period
Časové okno: 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
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Rate of PE During Treatment Period
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
16. února 2006
Primární dokončení (Aktuální)
26. října 2006
Dokončení studie (Aktuální)
26. října 2006
Termíny zápisu do studia
První předloženo
1. května 2006
První předloženo, které splnilo kritéria kontroly kvality
1. května 2006
První zveřejněno (Odhad)
3. května 2006
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
4. září 2018
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
30. srpna 2018
Naposledy ověřeno
1. srpna 2018
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Kardiovaskulární choroby
- Cévní onemocnění
- Zlomeniny, kosti
- Rány a zranění
- Zranění nohou
- Embolie a trombóza
- Zlomeniny stehenní kosti
- Zranění kyčle
- Zlomeniny kyčle
- Tromboembolismus
- Molekulární mechanismy farmakologického působení
- Inhibitory enzymů
- Fibrinolytická činidla
- Činidla modulující fibrin
- Inhibitory proteázy
- Inhibitory faktoru Xa
- Antitrombiny
- Inhibitory serinových proteináz
- Antikoagulancia
- Fondaparinux
- PENTA
Další identifikační čísla studie
- AR3106335
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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