Development of a Predictive Algorithm for a Hemoglobin Value of Less Than 10 g/dl Postoperatively in Scheduled Hip or Knee Arthroplasty (Predi_Hb)

September 11, 2023 updated by: Fondation Hôpital Saint-Joseph
Hip (THR) or knee (KT) prosthetic surgery is a bleeding surgery with an average blood spoliation of about 1 liter and an average decrease of about 3 g/dl in hemoglobinemia (Hb). Consequently, anemia is observed postoperatively in almost all patients (between 85% and 99% depending on the preoperative Hb value). In all cases, anemia-related events delay the patient's recovery, favor the occurrence of complications and prolong the length of stay. The immediate treatment of acute postoperative anemia is based on transfusion of red blood cells (RBCs). However, this presents several risks for the patient. The first is immediate and associated with the procedure: risk of error with ABO/Rhesus incompatibility, sepsis, pulmonary edema, etc. The second is a medium-term risk, with an increased risk of infection after prosthetic hip or knee surgery. In the long term, immediate postoperative blood transfusion is associated with higher mortality. In order to reduce the likelihood of a patient receiving RGCs, strategies have been developed within a "Patient Blood Management" (PBM), which could be translated as "Personalized Blood Transfusion Management". This strategy is based on 3 pillars: preoperatively, to ensure a patient's hemoglobin level of at least 13 g/dl; during the procedure, to limit blood loss; and postoperatively, to limit the indications for blood transfusion and the number of RGCs to the strict necessary. As the main determinant to trigger the prescription of a blood transfusion is the Hb value, the objective is that the lowest value of hemoglobinemia (Hb_nadir) postoperatively is as close as possible to 10 g/dl. The objective of this study is to describe, by means of the data available in the computerized patient record of patients undergoing scheduled THR or PTG operations at the Paris Saint Joseph Hospital, a prediction equation for Hb_nadir < 10 g/dl and, thus, to prescribe iron and ESAs only in patients who require them.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1041

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

- Patient operated on for elective hip or knee arthroplasty within the Paris Saint Joseph hospital site (HPSJ) between January 1, 2019 and December 31, 2021. Over the 36-month period, 1281 patients underwent THP (approximately 60%) or TKP (approximately 40%) surgery.

Description

Inclusion Criteria:

- Patient operated on for elective hip or knee arthroplasty within the Paris Saint Joseph hospital site (HPSJ) between January 1, 2019 and December 31, 2021. Over the 36-month period, 1281 patients underwent THP (approximately 60%) or TKP (approximately 40%) surgery.

Exclusion Criteria:

  • Patient who received iron infusion and/or injections of erythropoiesis stimulating agents within one month prior to surgery
  • Patient who received an infusion of packed red blood cells in the month prior to surgery
  • Absence of preoperative hemoglobinemia
  • No postoperative hemoglobinemia
  • Patient who had surgery in the previous month
  • Patient operated on both sides (hip or knee) during the same operation
  • Patient operated in emergency
  • Patient with a hereditary anemia
  • Patient opposing the use of his data for this research
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of the statistical model for predicting patients with a postoperative hemoglobin value (Hb_nadir) will be < 10 g/dl
Time Frame: Year1
This outcome corresponds to the Quality of the prediction obtained on the validation cohort.
Year1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Hôpital Saint-Joseph

Investigators

  • Principal Investigator: Pascal ALFONSI, MD, Fondation Hôpital Saint-Joseph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2022

Primary Completion (Actual)

October 28, 2022

Study Completion (Actual)

September 11, 2023

Study Registration Dates

First Submitted

October 31, 2022

First Submitted That Met QC Criteria

October 31, 2022

First Posted (Actual)

November 4, 2022

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Predi_Hb

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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