Patient Blood Management in Orthopedic Surgical Patients in Turkey

NCT05319223 | Unknown DMC

• 1 other identifier: 110-627-21
• Study Type: observational
• Target: 369
• Locations: 1 country
• Sites: 1

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 Blood Management (PBM), which is "the timely application of evidence-based medical and surgical concepts designed to maintain haemoglobin concentration, optimize hemostasis and minimize blood loss in an effort to improve patient outcome. There is mounting evidence that multimodal patient blood management (PBM) programmes can be effective at improving postoperative outcomes and reducing perioperative blood transfusions and costs The Turkish Society of Anaesthesiologists PBM Task Force has been working on this subject and studied transfusion practice throughout all through the peri-operative periods. Unfortunately we documented a high transfusion rate in major surgical patients in Turkey. One of the surgeries, that has high transfusion rate, was orthopaedic surgery. According to our recent data we planned to implement PBM in major orthopaedic surgical patients and evaluate the effects PBM in transfusion rate and patient outcomes. While some elements of PBM have a strong evidence base in hip or knee replacement, such as the use of tranexamic acid (TXA) the evidence for preoperative anaemia optimisation with iron is less robust. Implementing PBM all through the operative period gains more importance.

Conditions

Arthropathy

Keywords

Arthroplasty; patient blood management; anemia; İron deficiency

Outcome Measures

Primary Outcomes (1)

• red cell transfusion

  change in red blood cell transfusion rate

  3 days

Secondary Outcomes (1)

• cost

  3 days

Study Arms (2)

Patient management group

patient blood management group

Behavioral: patient blood management

Control

control

Interventions

patient blood management BEHAVIORAL

three pillars of patient blood management will be applied

Patient management group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing arthroplasty with anemia

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Prof. Serdar Gunaydin: lead

Study Sites (1)

Ankara University

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Joint Diseases; Anemia; Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hypochromic; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Cigdem YILDIRIM GUCLU

  Ankara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cigdem YILDIRIM GUCLU

CONTACT

+905324576648; drcigdemyldrm@yahoo.com.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: April 8, 2022
• Study Start: February 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 8, 2022

Record last verified: 2022-03

Locations

TU (1)