NCT02519088

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
477

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 10, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 12, 2015

Status Verified

October 1, 2015

Enrollment Period

2 months

First QC Date

August 3, 2015

Last Update Submit

October 8, 2015

Conditions

Postoperative Anemia

Keywords

Homologous Blood TransfusionTotal Hip ReplacementPatient Blood Management

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • pPBM Computer Simulation

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who electively underwent primary THA in 2013 and 2014

You may qualify if:

  • primary THA on patients with coxarthrosis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Krankenhaus der Barmherzigen Brüder Trier

Trier, Rhineland-Palatinate, 54292, Germany

Location

Study Officials

  • Ion-Andrei Popescu, MD

    Krankenhaus der Barmherzigen Brüder Trier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ion-Andrei Popescu, MD

Study Record Dates

First Submitted

August 3, 2015

First Posted

August 10, 2015

Study Start

August 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

October 12, 2015

Record last verified: 2015-10

Locations

DE(1)