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

Postoperative Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02519088
• Other study ID #: KrankenhausBBT
• Status: Completed
• Phase: N/A
• First received: August 3, 2015
• Last updated: October 8, 2015
• Start date: August 2015
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Krankenhaus der Barmherzigen Brüder Trier
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Description:

Retrospective audit of 470 consecutive primary THA in 2013 and 2014

Recruitment information / eligibility

• Status: Completed
• Enrollment: 477
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Postoperative Anemia

Locations

Country	Name	City	State
Germany	Krankenhaus der Barmherzigen Brüder Trier	Trier	Rheinland-Pfalz

Sponsors (1)

Lead Sponsor	Collaborator
Krankenhaus der Barmherzigen Brüder Trier

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No