E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with iron deficiency anemia scheduled to undergo orthopedic surgery with high risk of bleeding |
|
E.1.1.1 | Medical condition in easily understood language |
Patients with anemia, scheduled to undergo orthopedic surgery |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10058829 |
E.1.2 | Term | Elective surgery |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10044088 |
E.1.2 | Term | Total hip replacement |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10005127 |
E.1.2 | Term | Bleeding postoperative |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066573 |
E.1.2 | Term | Chronic iron deficiency anemia |
E.1.2 | System Organ Class | 10005329 - Blood and lymphatic system disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10057129 |
E.1.2 | Term | Revision of total knee arthroplasty |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051536 |
E.1.2 | Term | Intraoperative bleeding |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022975 |
E.1.2 | Term | Iron deficiency anemia secondary to blood loss (chronic) |
E.1.2 | System Organ Class | 10005329 - Blood and lymphatic system disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10069749 |
E.1.2 | Term | Internal fixation of spine |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051386 |
E.1.2 | Term | Wound bleeding |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10020096 |
E.1.2 | Term | Hip arthroplasty |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022976 |
E.1.2 | Term | Iron deficiency anemia secondary to inadequate dietary iron intake |
E.1.2 | System Organ Class | 10005329 - Blood and lymphatic system disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10051060 |
E.1.2 | Term | Hip surgery |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039727 |
E.1.2 | Term | Scoliosis surgery |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049130 |
E.1.2 | Term | Back surgery |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10023469 |
E.1.2 | Term | Knee arthroplasty |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022977 |
E.1.2 | Term | Iron deficiency anemia, unspecified |
E.1.2 | System Organ Class | 10005329 - Blood and lymphatic system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020102 |
E.1.2 | Term | Hip replacement |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10057128 |
E.1.2 | Term | Revision of hip arthroplasty |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10044094 |
E.1.2 | Term | Total knee replacement |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049662 |
E.1.2 | Term | Knee surgery NOS |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022974 |
E.1.2 | Term | Iron deficiency anemia |
E.1.2 | System Organ Class | 10005329 - Blood and lymphatic system disorders |
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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 main objective of this study is to evaluate the effect of the administration of ferric carboxymaltose on transfusion requirements (units of packed cells) |
|
E.2.2 | Secondary objectives of the trial |
- blood transfusion rate
- blood test results (hemoglobin, hematocrit, ferritin, transferrin)
- immune function (CRP, leucocytes, NT-proBNP)
- Quality of Life (SF-12)
- transthoracal echocardiography
- incidence of infections
- safety
- postoperative complications
- length of hospital stay |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients undergoing orthopedic surgery with risk of high blood loss
- anemia (Hb >= 8 g/dL and < 13 g/dL (men) respectively < 12 g/dL (women)
- ferritin < 100 µg/L or 100-300 with TSat < 20%
- age >= 18 years
- sign the informed consent form
|
- Elektiver orthopädischer Eingriff mit einer perioperativen Transfusionswahrscheinlichkeit von mindestens 10 %
- Hb >= 8 g/dl und < 13 g/dl (Männer) bzw. 12 g/dl (Frauen)
- Ferritin < 100 µg/l oder 100-300 µg/l und TSat < 20%
- Schriftliche Einwilligung des Patienten |
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E.4 | Principal exclusion criteria |
- history of thromboembolic events for the last 5 years
- concurrent medical condition(s) that would prevent compliance or participation or jeopardize the health of the patient
- Hypersensitivity to any component of the formulation
- transfusion within 1 month prior to study inclusion
- liver values 3 times higher than normal
- renal insufficiency (GFR < 30 mL/min/1,73 m²) |
- Patienten mit thromboembolischen Ereignissen innerhalb der letzten 5 Jahre
- Begleiterkrankungen, die die Compliance oder Teilnahme verhindern oder die die Gesundheit der Patienten gefährden würden
- Allergie gegen das Studienmedikament
- Patienten, die innerhalb 30 Tagen vor Einschluss in die Studie Erythrozytenkonzentrate, Erythropoietin oder Eisen erhalten haben
- Leberinsuffizienz (Transaminasen >= 3x über dem oberen Normwert)
- chronische Niereninsuffizienz (GFR < 30 ml/min/1,73 m²) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Units of packed cells (from study inclusion (2-6 weeks prior to surgery) up to postoperative day 7) per patient |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From study inclusion (2-6 weeks prior to surgery) up to postoperative day 7 |
|
E.5.2 | Secondary end point(s) |
- transfusion rate
- laboratory results (Hb, HK, MCV, MCH, ferritin, transferrin)
- immune function (CRP, leucocytes, NT-proBNP)
- transthoracal echocardiographia
- Quality of Life SF-12
- rate of infections
- rate of complications
- mortality
- length of hospital stay |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- From study inclusion (2-6 weeks prior to surgery) up to postoperative day 7
- on postoperative day 7
- 6 weeks postoperatively |
|
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 | 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 | 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
|
End of trial is the last visit of the last subject undergoing the trial |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
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 | 3 |
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 |