E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Bleeding in patients suffering femur neck fracture |
Sangrado en pacientes que presentan fractura de cuello de fémur |
|
E.1.1.1 | Medical condition in easily understood language |
Lost of blood in patients suffering hip fracture |
Pérdidas de sangre en pacientes que presentan fractura de cadera |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10053220 |
E.1.2 | Term | Hip injury |
E.1.2 | System Organ Class | 100000004863 |
|
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 |
Reduction in the number of patients who need a red blood cell transfusion after femur fracture |
Reducción en el número de pacientes que necesitan transfusiones tras una fractura de fémur |
|
E.2.2 | Secondary objectives of the trial |
Reduction in the amount of red cell packs transfused in patients with femur fracture Reduction in the calculated blood losses in patients with femur fracture Assessment of safety of tranexamic acid in patients with femur fracture |
Reducción en la cantidad de concentrados de hematíes transfundidos en pacientes con fractura de fémur Reducción en el sangrado estimado de los pacientes con fractura de fémur Verificación de la seguridad del ácido tranexámico en pacientes con fractura de fémur |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age > 64 Femur fracture that needs surgical treatment |
Edad >64 años Fractura de fémur que necesitará tratamiento quirúrgico |
|
E.4 | Principal exclusion criteria |
Tranexamic acid allergy Thrombogenic status Epilepsy Multiple fractures Colour blindness |
Alergia a ácido tranexámico Estado trombogénico Epilepsia Fracturas múltiples Ceguera a los colores |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Reduction in the transfusion rate of 30% |
Reducción en la tasa de transfusiones del 30% |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
30 days after trauma femur fracture |
30 días después de la fractura de fémur |
|
E.5.2 | Secondary end point(s) |
Reduction in 50% of patients who need more than one red blood cell concentrate |
Reducción del 50% de los pacientes que necesitan más de una bolsa de sangre |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
30 days after trauma femur fracture |
30 días después de la fractura de fémur |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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 | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
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.8.5 | The trial involves multiple Member States | No |
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 | No |
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 trial finnishes when the number of recruited valid cases is 276. |
El ensayo acaba al reclutarse 276 casos válidos. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |