Patients with iron deficiency anemia scheduled to undergo orthopedic surgery with high risk of bleeding MedDRA version: 14.1 Level: PT Classification code 10058829 Term: Elective surgery System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: LLT Classification code 10044088 Term: Total hip replacement System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: LLT Classification code 10005127 Term: Bleeding postoperative Syste
Conditions
Interventions
Trade Name: Ferinject 50mg Eisen/ml
Pharmaceutical Form: Infusion
INN or Proposed INN: Ferric Carboxymaltose
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration n
Sponsors
University Hospital Muenster
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients undergoing orthopedic surgery with risk of high blood loss - anemia (Hb >= 8 g/dL and = 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 - 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;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
| Measure | Time frame |
|---|---|
| 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;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 | — |
Countries
Germany
Contacts
Public ContactDept. of Anesthesiology
University Hospital Muenster
Outcome results
None listed