Effect of Intravenous Ferric Carboxymaltose on Hemoglobin Response Among Patients With Acute Isovolemic Anemia after Reverse Total Shoulder Arthroplasty
- Conditions
- Diseases of the musculoskeletal system and connective tissue
Recruitment & Eligibility
- Status
- Terminated
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
?Primary or secondary omarthritis patients with the age of over 60
?Patients who underwent reverse total shoulder arthroplasty who meet one or more of the following criteria A to C
A.Postoperative hemoglobin levels below 13 g / dL for men and below 12 g / dL for women
B.Postoperative hemoglobin level lower than 3g / dL compared to preoperative blood test
C.Postoperative Hematocrit Levels Less Than 36%
?Irreparable massive rotator cuff tear patients with the age of over 60
?Cuff tear arthrospathy patients with the age of over 60
?Patients who agreed to participate in the clinical study
(Patients with the age of over 70 shall be included only when they are capable of understanding the contents of and voluntarily agree to participate in this study. Patients with the age of over 70 needs to be included considering the general age distribution of Rotator Cuff Tear patients.)
-Further consideration for the patients with the age of over 70
The degree and the speed of aging are different by person. Aging also causes hypofunction in liver, kidney, etc. even if there is no related disorder or illness. More characteristics and considerations related to aging are as follows:
1) Pharmacokinetic and pharmacodynamic Changes: It is generally known that aging has a limited influence on the absorption of medicines. However, aging may lead to different phamacokinetic profiles such as decreased metabolic capability due to reduced hepatic blood flow and changed hepatic enzyme activity, deteriorated excretory function due to reduced kidney blood flow and so on. In terms of pharmacodynamics, there has been little known about the effects of aging, but there is some possibility that aging may lead to different medicine reaction due to the change in the quantities of drug receptors and their affinity level.
2) Changes in body composition: For aged patients, we shall consider higher possibility of drug side effects due to accumulated drugs in the body because aging leads to the change in body composition such as more body fat and less water compared to average adult. Aging may also affect protein binding and its volume of distribution due to decreased density of plasma albumin.
3) Polypharmacy and higher co-morbidities: The aged tend to have more co-morbidities and polyphamacy prescription because they are most likely to have other diseases on top of aging-related diseases. Therefore, we shall take an extra consideration for interactions between drug and disease as well as between drugs.
4) Cognitive and perceptual disorders: The aged may have cognitive and perceptual disorders such as dementia, depression or verbal language disorders.
5) Decreased social and physical activities: The aged may have a sense of loss due to loss of social role after retirement, decreased physical activities and/or deteriorated physical health.
Exclusion Criteria
Patients who fall under the following shall be excluded from this study.
1. Patients with low hemoglobin levels before surgery (female <12g / dL, male <13g / dL)
2.Patients with topical infection or septicemia on surgery site or in the upper limbs and also patients with neurologic abnormalities in the past
3.Patients with inflammatory or crystal-deposition arthritis
4.Patients hypersensitive to ferric medicines
5.Patients with uncontrollable hypertension with relaxing blood pressure with over 100mmHg
6.Patients with abnormal liver function (aspartate aminotransferase or alanine aminotransferase> 60 IU liters)
7.Patients with congenital or acquired blood coagulation disorders
8.Patients with preoperative liver or kidney disorders
9.Patients with significant cardiovascular diseases
10.Patients with fracture, revision arthroplasty, and severe deformity inoperable with conventional surgery
11.Patients hypersensitive or allergic to other non-oral ferric medicines
12.Patients with anemia other than sideropenic anemia (eg, microcytic anemia)
13.Patients with excessive iron overload or iron-use disorder
14.Patients with progressive bacteremia
15.Patients with acute or chronic infections (In case of patients with chronic infections, the benefit and the risk shall be assessed considering the inhibition of red blood cell formation)
16.Patients with asthma, eczema and atopic allergies or with medical history of these diseases in the past
17.Patients with allergies including drug allergies
18.Patients with immune or inflammatory diseases (eg, systemic lupus erythematosus, rheumatoid arthritis)
Early Termination Criteria
1.Patient’s death
2.If a patient needs hospitalization or treatment for a new serious disease
3.If a patient has a limitation of joint movement at the surgical site due to injury or disease
4.If a patient has infection after surgery
5.If a patient is out of contact in the course of observation
6.If a patient does not want to participate in the study due to side effects
7.Hemoglobin level drops below 8 g / dL after surgery or symptoms of acute anemia
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method postoperative hemoglobin
- Secondary Outcome Measures
Name Time Method Serum ferritin;Total iron-binding capacity;Transferrin saturation