Total Hip ReplacementNCT02750852
An Algorithm for Predicting Blood Loss and Transfusion Risk in Fast Track Total Hip Arthroplasty
An observational study of Total Hip Replacement and Blood Loss, run by Azienda Ospedaliera Bolognini di Seriate Bergamo.
Trial summary
Aim of these study is to create an algorithm, using data from patients that undergoing total hip arthroplasty, to predict blood loss after surgery and permit a safe domestic discharge. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Hip Replacement, Blood Loss
- What is being tested?
- Total hip arthroplasty, blood loss analysis
- Type of treatment
- Surgery or procedure
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to May 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 124 patients, in two different cohorts, undergoing total hip arthroplasty.
Who may be able to join
- Patients with hip arthritis
Who cannot join
- ASA 4 - 5
- Active treatment with warfarin
- Coagulation disorders
About this study
Aim of these study is to create an algorithm, using data from patients that undergoing total hip arthroplasty, to predict blood loss after surgery and permit a safe domestic discharge.
Read the detailed description
Two different cohorts of patients undergoing total hip arthroplasty will be analyzed to obtain data about hemoglobin trends. The first group will be used to obtain the algorithm, the second one to validate results of the first group, determining sensitivity and specificity.
- Conditions
- Total Hip Replacement, Blood Loss
- Being tested
- Total hip arthroplasty, blood loss analysis
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip arthroplasty, blood loss analysisProcedure or surgery
Data analysis about blood loss in total hip replacement
| Study group | Role | What they receive |
|---|---|---|
| Analysis group | Create an algorithm to predict blood loss using patients data Receives: Procedure: Total hip arthroplasty, blood loss analysis | |
| Control group | The algorithm was applied to analyze sensitivity and specificity Receives: Procedure: Total hip arthroplasty, blood loss analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Create an algorithm to predict blood loss after total hip arthroplasty
Data from the fist cohort of patients have been collected and analyzed to obtain an algorithm describing the trends of hemoglobin values after total hip arthroplasty. These algorithm was after applied to patients of a second cohort of consecutive patients undergoing total hip arthroplasty to determine specificity and sensitivity.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2016
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ReplacementStudies 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Bolognini di Seriate Bergamo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riccardo Compagnoni, Azienda Ospedaliera Bolognini di Seriate Bergamo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750852
- Sponsor's protocol ID
- Blood algorithm
- Status last verified
- Apr 2016
- First submitted
- 21 Apr 2016
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Algorithm for Predicting Blood Loss and Transfusion Risk in Fast Track Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02750852
- Acronym / sponsor ID
- Blood algorithm
- Conditions
- Total Hip Replacement, Blood Loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Bolognini di Seriate BergamoUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (estimated)
- First posted
- 26 Apr 2016 (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.
Aim of these study is to create an algorithm, using data from patients that undergoing total hip arthroplasty, to predict blood loss after surgery and permit a safe domestic discharge.
Detailed description
Two different cohorts of patients undergoing total hip arthroplasty will be analyzed to obtain data about hemoglobin trends. The first group will be used to obtain the algorithm, the second one to validate results of the first group, determining sensitivity and specificity.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Analysis group | – | Procedure: Total hip arthroplasty, blood loss analysisCreate an algorithm to predict blood loss using patients data |
| Control group | – | Procedure: Total hip arthroplasty, blood loss analysisThe algorithm was applied to analyze sensitivity and specificity |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 124 patients, in two different cohorts, undergoing total hip arthroplasty.
Key inclusion criteria (1 listed)
- Patients with hip arthritis
Key exclusion criteria (3 listed)
- ASA 4 - 5
- Active treatment with warfarin
- Coagulation disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total hip arthroplasty, blood loss analysisData analysis about blood loss in total hip replacement | Procedure or surgery | Analysis group, Control group |
Primary outcome
Create an algorithm to predict blood loss after total hip arthroplasty
Time frame: 3 months
Data from the fist cohort of patients have been collected and analyzed to obtain an algorithm describing the trends of hemoglobin values after total hip arthroplasty. These algorithm was after applied to patients of a second cohort of consecutive patients undergoing total hip arthroplasty to determine specificity and sensitivity.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Hip Replacement and Blood Loss, run by Azienda Ospedaliera Bolognini di Seriate Bergamo.
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 3 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: status not confirmed, as of the sponsor's last update on 26 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Create an algorithm to predict blood loss after total hip arthroplasty (time frame: 3 months). 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 26 Apr 2016.