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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date August 3, 2015
First Posted Date August 10, 2015
Last Update Posted Date October 12, 2015
Study Start Date August 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 5, 2015)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 5, 2015)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A New Approach to a Personalized Patient Blood Management Program (pPBM) in Total Hip Arthroplasty (THA)
Official Title A New Approach to a Personalized Patient Blood Management Program in Total Hip Arthroplasty
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 Type Observational
Study Design Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who electively underwent primary THA in 2013 and 2014
Condition Postoperative Anemia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 8, 2015)
477
Original Estimated Enrollment
 (submitted: August 5, 2015)
470
Actual Study Completion Date October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02519088
Other Study ID Numbers KrankenhausBBT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ion-Andrei Popescu, MD, Krankenhaus der Barmherzigen Brüder Trier
Study Sponsor Krankenhaus der Barmherzigen Brüder Trier
Collaborators Not Provided
Investigators
Principal Investigator: Ion-Andrei Popescu, MD Krankenhaus der Barmherzigen Brüder Trier
PRS Account Krankenhaus der Barmherzigen Brüder Trier
Verification Date October 2015