Postoperative AnemiaNCT02519088
A New Approach to a Personalized Patient Blood Management Program (pPBM) in Total Hip Arthroplasty (THA)
An observational study of Postoperative Anemia, run by Krankenhaus der Barmherzigen Brüder Trier at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Anemia
- How many people
- 477 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2015to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who electively underwent primary THA in 2013 and 2014
Who may be able to join
- primary THA on patients with coxarthrosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Krankenhaus der Barmherzigen Brüder Trier
Trier, Rhineland-Palatinate, 54292
About this study
Official title: A New Approach to a Personalized Patient Blood Management Program in Total Hip Arthroplasty
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.
Read the detailed description
Retrospective audit of 470 consecutive primary THA in 2013 and 2014
- Conditions
- Postoperative Anemia
- Keywords
- Homologous Blood Transfusion, Total Hip Replacement, Patient Blood Management
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: participants will be followed for the duration of hospital stay, an expected average of 10 days
Secondary outcomes (1)
pPBM Computer Simulation
Introducing the pPBM App as a safe blood-sparing strategy
Measured: participants will be followed for the duration of hospital stay, an expected average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 477 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krankenhaus der Barmherzigen Brüder Trier
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ion-Andrei Popescu, MD, Krankenhaus der Barmherzigen Brüder Trier
- Investigators
- Ion-Andrei Popescu, MD, Principal investigator, Krankenhaus der Barmherzigen Brüder Trier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519088
- Sponsor's protocol ID
- KrankenhausBBT
- Status last verified
- Oct 2015
- First submitted
- 3 Aug 2015
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Approach to a Personalized Patient Blood Management Program in Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02519088
- Acronym / sponsor ID
- KrankenhausBBT
- Conditions
- Postoperative Anemia
- Keywords
- Homologous Blood Transfusion, Total Hip Replacement, Patient Blood Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 477 participants (actual)
- Lead sponsor
- Krankenhaus der Barmherzigen Brüder TrierUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 10 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who electively underwent primary THA in 2013 and 2014
Key inclusion criteria (1 listed)
- primary THA on patients with coxarthrosis
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
pPBM Computer Simulation
Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ion-Andrei Popescu, MD principal investigator
Krankenhaus der Barmherzigen Brüder Trier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Anemia, run by Krankenhaus der Barmherzigen Brüder Trier at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015.