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Completed

NCT Number: NCT04398238

Transfusion Rates in Total Hip Replacement Before/After the Implementation of a Patient Blood Management Program.

Retrospective observational study: impact of a peri-operative patient blood management program (PBM) on transfusion rates of patients undergoing elective hip replacement.

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Key information

Conditions

Anemia (Diagnosis) Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Arthroplasty Disease Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Iron-deficiency Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Transfusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sandra Giannone

Bologna, BO, 40128, Italy

About this study

A Patient Blood Management (PBM) program was implemented in year 2019 in our institution: patient scheduled for elective total hip replacement underwent pre-operative screening about one month before surgery, and those with pre-operative hemoglobin < 13 g/dl were screened for possible causes and treatment of anemia.

Data from two different time frames, before and after the implementation of the program, were collected to study the change in clinical outcomes such as transfusion rates, length of stay, etc.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • undergoing elective hip replacement in the selected time-frame
  • American Society of Anesthesiology (ASA) status 1-2-3
  • age >18

Exclusion criteria

  • patients not undergoing screening as outpatients at pre-operative clinic

Treatment and study plan

evaluation by transfusion medicine specialist

Combination Product

screening for anemia causes and treatment: iron/folate/vitamin B12 supplementation, Erythropoietin administration if indicated

Primary outcomes

  1. transfusion rates

    Time frame: from day of surgery till day of discharge, up to 60 days

    percentage of patients undergoing hip replacement who receive at least one unit of concentrated red cells during or after surgery

Secondary outcomes

  1. minimum hemoglobin

    Time frame: from day of surgery till day of discharge, up to 60 days

    minimum hemoglobin reached after surgery

  2. hemoglobin at discharge

    Time frame: from day of surgery till day of discharge, up to 60 days

    last measured hemoglobin before discharge from hospital

  3. length of stay

    Time frame: from day of surgery till day of discharge, up to 60 days

    total days of hospital stay from admission to discharge

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

"Change in Transfusion Rates of Patients Undergoing Elective Total Hip Replacement Before/After the Implementation of a Peri-operative Patient Blood Management Program: a Retrospective Observational Study.

Acronym: pbm-hip

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
May 21, 2020
Registry last updated
May 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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