Status:
UNKNOWN
Patient Blood Management in Orthopedic Surgical Patients in Turkey
Lead Sponsor:
Prof. Serdar Gunaydin
Conditions:
Arthropathy
Eligibility:
All Genders
18+ years
Brief Summary
Transfusion practice for surgical patients has changed from replacing surgically lost blood with allogeneic blood transfusions to implementing strategies that reduce transfusion requirements. Patient ...
Detailed Description
Active PBM Implementation: Patients undergoing hip or knee arthroplasty will be treated as follows: PBM will be performed as shown in the graph below "PBM Implementation Group". Active PBM group will...
Eligibility Criteria
Inclusion
- In order to be eligible to participate in this trial, an individual must meet all of the following criteria:
- Signed patient informed consent
- Male or female patient at least 18 years old
- Patients scheduled for an elective major orthopaedic surgery (hip arthroplasty, knee arthroplasty, primary and revision operations)
- Patients with confirmed iron deficiency anemia (IDA), defined as Hb 100-130 g/L, and serum ferritin \< 100 ng/ml or TSAT \< 20%.
- Patients with iron deficiency anemia will be taken into surgery at least 3 weeks after the treatment.
Exclusion
- Patients that undergo emergency surgical procedure and trauma cases are excluded from the study.
- Patients with non-iron deficiency anaemia (thalassemia, sickle cell anaemia and etc.)
- Patients with renal anaemia (Hb \< 130 g/L and CCL \< 50 mL/min, irrespective of iron parameters) or any diagnosis that require EPO will be excluded
- Patients with known anaphylactic/hypersensitivity reactions to parenteral iron products.
- Patients with iron overload or disturbances in utilization of iron (e.g. haemochromatosis, hemosiderosis)
- Patients with ≥3 times increase in aspartate aminotransferase or alanine aminotransferase as per reference range.
- Patients with excessive blood loss requiring massive transfusion (≥ 10 more red blood cell units)
- Patients with known myelodysplastic syndromes.
- Patients with chronic kidney disease with an estimated GFR \< 30 ml/min or with end-stage renal disease requiring scheduled dialysis.
- Patients with known urinary tract infections with urea-splitting bacteria
- Any patient judged to lack the ability to give informed consent or perform the trial assessments (e.g. due to dementia)
- Women who are pregnant or breast feeding
- Intention to become pregnant during the course of the study,
- Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases (Female participants who are surgically sterilized / hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential),
- Known or suspected non-compliance, drug or alcohol abuse,
- Participation in another study with investigational drug within the 30 days preceding and during the present study
Key Trial Info
Start Date :
February 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
369 Patients enrolled
Trial Details
Trial ID
NCT05319223
Start Date
February 1 2022
End Date
December 1 2022
Last Update
April 8 2022
Active Locations (1)
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1
Ankara University
Ankara, Turkey (Türkiye)