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

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ClinicalTrials.gov Identifier: NCT02519088
Recruitment Status : Completed
First Posted : August 10, 2015
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Ion-Andrei Popescu, MD, Krankenhaus der Barmherzigen Brüder Trier

Brief Summary:

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.


Condition or disease
Postoperative Anemia

Detailed Description:
Retrospective audit of 470 consecutive primary THA in 2013 and 2014

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Study Type : Observational
Actual Enrollment : 477 participants
Time Perspective: Retrospective
Official Title: A New Approach to a Personalized Patient Blood Management Program in Total Hip Arthroplasty
Study Start Date : August 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who electively underwent primary THA in 2013 and 2014
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519088


Locations
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Germany
Krankenhaus der Barmherzigen Brüder Trier
Trier, Rheinland-Pfalz, Germany, 54292
Sponsors and Collaborators
Krankenhaus der Barmherzigen Brüder Trier
Investigators
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Principal Investigator: Ion-Andrei Popescu, MD Krankenhaus der Barmherzigen Brüder Trier
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Responsible Party: Ion-Andrei Popescu, MD, Krankenhaus der Barmherzigen Brüder Trier
ClinicalTrials.gov Identifier: NCT02519088    
Other Study ID Numbers: KrankenhausBBT
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015
Keywords provided by Ion-Andrei Popescu, MD, Krankenhaus der Barmherzigen Brüder Trier:
Homologous Blood Transfusion
Total Hip Replacement
Patient Blood Management