E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hip fractured subjects on warfarin therapy |
Soggetti con frattura di femore in terapia con warfarin |
|
E.1.1.1 | Medical condition in easily understood language |
Hip fractured subjects on warfarin therapy |
Soggetti con frattura di femore in terapia con warfarin |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10020100 |
E.1.2 | Term | Hip fracture |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the study is to evaluate, in comparison with usual care practice, the efficacy of an established pharmacological reversal approach with Phytonadione (vitamin K1) on reducing time to decrease INR until the safe cut off value recommended for surgery in hip fractured patients taking warfarin. |
L¿obiettivo primario di questo studio ¿ valutare, rispetto ad una gestione usuale, l¿efficacia di un algoritmo procedurale che prevede la somministrazione di fitomenadione (vitamina K1) sui tempi di riduzione dei valori di INR sino al cut off raccomandato per l¿intervento chirurgico. |
|
E.2.2 | Secondary objectives of the trial |
- to evaluate, in comparison with usual care practice, the proportion of patients in the intervention group who undergo surgery within 48 hours or the length of stay less than 7 days between the two groups; - to evaluate safety of doses and route of vitamin K established by our protocol in terms of thromboembolic events and in-hospital mortality; - to evaluate safety of doses and route of vitamin K established by our protocol in terms of adverse drug reactions.
|
- valutare, rispetto ad una gestione usuale, la proporzione di pazienti che nel gruppo intervento viene sottoposta ad intervento chirurgico entro le 48 ore e la proporzione di pazienti che nei due gruppi ha una durata di degenza inferiore a 7 giorni; - valutare la sicurezza di vitamina K, delle dosi e della via di somministrazione utilizzate, in termini di eventi tromboembolici e mortalit¿; - valutare la sicurezza di vitamina K, delle dosi e della via di somministrazione utilizzate, in termini di eventi avversi al farmaco.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-subject, male and female, aged 65 years or older with a diagnosis of hip fracture with indication for surgical treatment; -subject taking warfarin; -subject willing and able to give written informed consent for participation in the study.
|
- soggetti, maschi e femmine, di età maggiore o uguale a 65 anni con diagnosi di frattura di femore candidati all’intervento chirurgico; - soggetti che assumono warfarin; - soggetti capaci di dare il proprio consenso informato alla partecipazione allo studio.
|
|
E.4 | Principal exclusion criteria |
- subject with multiple trauma fractures; -subjects with mechanical heart valves or venous thromboebolism within 3 months or thrombophilia; - subject with hypersensivity to Phytonadion or to any of its excipients; - subject with severe hepatic failure; - any other condition that, in the clinical judgment of the investigator, means that it would not be in the best interests of the subject to enter the study; - subject currently enrolled in other trial; - subject unwilling or unable to give the informed consent.
|
- soggetti politraumatizzati; - soggetti con valvole protesiche meccaniche, con tromboembolismo venoso recente (nei 3 mesi precedenti) o con trombofilia nota; - soggetti con nota ipersensibilità a Fitomenadione o ai suoi eccipienti; - soggetti con insufficienza epatica grave; - qualsiasi condizione che, a giudizio clinico, rappresenti una priorità per il benessere del paziente rispetto alla partecipazione allo studio o per cui la partecipazione allo studio ne comprometterebbe le cure; - soggetti arruolati in altri trial clinici; - soggetti incapaci di fornire il proprio consenso informato o non consenzienti.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome will be assessed by the difference in the proportion of persons who reach the safe cut off for the INR within 24 hours. |
L’end point primario verrà valutato sulla base della differenza fra la proporzione di soggetti che raggiungerà il valore cut off di INR entro le 24 ore. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
The secondary outcomes are difference in the proportion of: - number of patients who undergo surgery within 48 hours and number of patient with an hospital stay less than 7 days; - cases with thromboembolic events and in-hospital mortality; - cases with allergic or anaphylactic reactions after administration of vitamin K.
|
Gli end points secondari verranno valutati sulla base della differenza fra: - numero di soggetti che verranno sottoposti ad interevnto chirurgico entro le 48 ore; - numero di soggetti che avranno una degenza inferiore a 7 giorni; - numero di eventi tromboembolici e casi di morte intraospedaliera; - casi di reazioni allergiche o anafilattiche.
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
in hospital stay |
degenza ospedaliera |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Gestione clinica usuale |
usual care |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of the study is determinated by the end of the hospital stay of the last subject discharged among subjects enrolled |
La conclusione della sperimentazione corrisponde con il termine della degenza ospedaliera dell'ultimo soggetto dimesso tra i soggetti arruolati. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |