Preoperative Intravenous Ferric Carboxymaltose (Ferinject) in Patients with Orthopaedic Surgery and High Risk of Blood Loss - PRIVIRO

Conditions: Patients with iron deficiency anemia scheduled to undergo orthopedic surgery with high risk of bleeding
MedDRA version: 14.1Level: PTClassification code 10058829Term: Elective surgerySystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1Level: LLTClassification code 10044088Term: Total hip replacementSystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1Level: LLTClassification code 10066573Term: Chronic iron deficiency anemiaSystem Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1Level: LLTClassification code 10005127Term: Bleeding postoperativeSystem Organ Class: 10022117 - Injury, poisoning and procedural complications
MedDRA version: 14.1Level: LLTClassification code 10057129Term: Revision of total knee arthroplastySystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1Level: LLTClassification code 10051536Term: Intraoperative bleedingSystem Organ Class: 10022117 - Injury, poisoning and procedural complications
MedDRA version: 14.1Level: LLTClassification code 10022975Term: Iron deficiency anemia secondary to blood loss (chronic)System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1Level: PTClassification code 10069749Term: Internal fixation of spineSystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1Level: LLTClassification code 10051386Term: Wound bleedingSystem Organ Class: 10022117 - Injury, poisoning and procedural complications

Registration Number: EUCTR2010-024115-14-DE

Lead Sponsor: niversity Hospital Muenster

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140

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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of this study is to evaluate the effect of the administration of ferric carboxymaltose on transfusion requirements (units of packed cells);Secondary Objective: - blood transfusion rate <br>- blood test results (hemoglobin, hematocrit, ferritin, transferrin)<br>- immune function (CRP, leucocytes, NT-proBNP)<br>- Quality of Life (SF-12)<br>- transthoracal echocardiography<br>- incidence of infections<br>- safety<br>- postoperative complications<br>- length of hospital stay;Primary end point(s): Units of packed cells (from study inclusion (2-6 weeks prior to surgery) up to postoperative day 7) per patient;Timepoint(s) of evaluation of this end point: From study inclusion (2-6 weeks prior to surgery) up to postoperative day 7

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - transfusion rate<br>- laboratory results (Hb, HK, MCV, MCH, ferritin, transferrin)<br>- immune function (CRP, leucocytes, NT-proBNP)<br>- transthoracal echocardiographia<br>- Quality of Life SF-12<br>- rate of infections<br>- rate of complications<br>- mortality<br>- length of hospital stay;Timepoint(s) of evaluation of this end point: - From study inclusion (2-6 weeks prior to surgery) up to postoperative day 7<br>- on postoperative day 7<br>- 6 weeks postoperatively