A New Approach to a Personalized Patient Blood Management Program (pPBM) in Total Hip Arthroplasty (THA)

A New Approach to a Personalized Patient Blood Management Program in Total Hip Arthroplasty

The study evaluates the patient related risk and predictive factors concerning perioperative homologous blood cell transfusion (erythrocyte concentrate ) in THA patients in one EndoCert max-certified orthopedic hospital in Germany.

A patient oriented preoperative decision-making algorithm (a personalised Patient Blood Management or pPBM App) will be developed as a new patient-safety blood-sparing strategy.

The aim is to increase the patient safety by using the pPBM App and to reach a more efficient management of resources.

Study Overview

• Status: Completed
• Conditions: Postoperative Anemia

Detailed Description

Retrospective audit of 470 consecutive primary THA in 2013 and 2014

• Study Type: Observational
• Enrollment (Actual): 477

Contacts and Locations

Study Locations

• Germany
  • Rheinland-Pfalz
    • Trier, Rheinland-Pfalz, Germany, 54292
      • Krankenhaus der Barmherzigen Brüder Trier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who electively underwent primary THA in 2013 and 2014

Description

Inclusion Criteria:

• primary THA on patients with coxarthrosis

Exclusion Criteria:

• any kind of old or acute fractures about the basin and hip
• combined surgery, like first extracting a femur nail and than undergoing THA
• any other kind of combined or simultaneous surgery
• any kind of coagulopathy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Events and circumstances of Homologous Blood Transfusion (erythrocyte concentrate transfusion)	Multivariate analysis of predictive variables like age, sex, BMI, hip and belly circumference, chronic kidney disease, chronic cardio-vascular disease, chronic inflammatory disease, diabetes mellitus, cancer, ASA Score, cemented, hybrid or not cemented prosthesis, surgery duration, medication and hemoglobin level before surgery	participants will be followed for the duration of hospital stay, an expected average of 10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pPBM Computer Simulation	Introducing the pPBM App as a safe blood-sparing strategy	participants will be followed for the duration of hospital stay, an expected average of 10 days

Collaborators and Investigators

• Sponsor: Krankenhaus der Barmherzigen Brüder Trier
• Investigators: Principal Investigator: Ion-Andrei Popescu, MD, Krankenhaus der Barmherzigen Brüder Trier

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: August 3, 2015
• First Submitted That Met QC Criteria: August 5, 2015
• First Posted (Estimate): August 10, 2015

Study Record Updates

• Last Update Posted (Estimate): October 12, 2015
• Last Update Submitted That Met QC Criteria: October 8, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Patient Blood Management; Total Hip Replacement; Homologous Blood Transfusion
• Other Study ID Numbers: KrankenhausBBT