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Completed

NCT Number: NCT02519088

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Krankenhaus der Barmherzigen Brüder Trier

Trier, Rhineland-Palatinate, 54292, Germany

About this study

Retrospective audit of 470 consecutive primary THA in 2013 and 2014

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Events and circumstances of Homologous Blood Transfusion (erythrocyte concentrate transfusion)

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days

    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

Secondary outcomes

  1. pPBM Computer Simulation

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days

    Introducing the pPBM App as a safe blood-sparing strategy

Sponsors and collaborators

Lead sponsor

Krankenhaus der Barmherzigen Brüder Trier

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 10, 2015
Registry last updated
Oct 12, 2015

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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