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Hip Fracture Study of GSK576428 (Fondaparinux Sodium)
30 augustus 2018 bijgewerkt door: 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.
Studie Overzicht
Studietype
Ingrijpend
Inschrijving (Werkelijk)
48
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
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- GSK Investigational Site
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
20 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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).
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Rate of Major Bleeding During Treatment Period
Tijdsspanne: 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).
|
From the first study drug injection up to Day 17
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Rate of PE During Treatment Period
Tijdsspanne: 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.
|
Up to Day 17
|
Rate of DVT During Treatment Period
Tijdsspanne: Up to Day 17
|
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.
|
Up to Day 17
|
Rate of Proximal DVT During Treatment Period
Tijdsspanne: 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.
|
Up to Day 17
|
Rate of Distal Only DVT During Treatment Period
Tijdsspanne: 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.
|
Up to Day 17
|
Number of Participants With Major Bleeding During Treatment Period
Tijdsspanne: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
|
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).
|
From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
|
Number of Participants With Minor Bleeding and Any Bleeding (Major and/or Minor Bleeding)
Tijdsspanne: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
|
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.
|
From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
|
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death
Tijdsspanne: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
|
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
Tijdsspanne: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
|
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)
|
Summary of Units Transfused
Tijdsspanne: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
|
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.
|
From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
|
Rate of Symptomatic DVT
Tijdsspanne: 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.
|
Up to Day 17
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
16 februari 2006
Primaire voltooiing (Werkelijk)
26 oktober 2006
Studie voltooiing (Werkelijk)
26 oktober 2006
Studieregistratiedata
Eerst ingediend
1 mei 2006
Eerst ingediend dat voldeed aan de QC-criteria
1 mei 2006
Eerst geplaatst (Schatting)
3 mei 2006
Updates van studierecords
Laatste update geplaatst (Werkelijk)
4 september 2018
Laatste update ingediend die voldeed aan QC-criteria
30 augustus 2018
Laatst geverifieerd
1 augustus 2018
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Hart-en vaatziekten
- Vaatziekten
- Breuken, bot
- Wonden en verwondingen
- Been verwondingen
- Embolie en trombose
- Femurfracturen
- Heup verwondingen
- Heupfracturen
- Trombo-embolie
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Fibrinolytische middelen
- Fibrine modulerende middelen
- Proteaseremmers
- Factor Xa-remmers
- Antithrombinen
- Serineproteïnaseremmers
- Anticoagulantia
- Fondaparinux
- PENTA
Andere studie-ID-nummers
- AR3106335
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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