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

Completed

• Conditions: Postoperative Anemia

• Registration Number: NCT02519088
• Lead Sponsor: 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.

Detailed Description

Retrospective audit of 470 consecutive primary THA in 2013 and 2014

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-03
• Study First Submitted QC: 2015-08-05
• Study First Posted: 2015-08-10
• Status Verified: 2015-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-10-08
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 477

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Events and circumstances of Homologous Blood Transfusion (erythrocyte concentrate transfusion)	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

Name	Time	Method
pPBM Computer Simulation	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

Trial Locations

Locations (1)

Krankenhaus der Barmherzigen Brüder Trier; 🇩🇪 Trier, Rheinland-Pfalz, Germany