AnemiaNCT02838706
Elderly With Hip Fracture and Perioperative Hemoglobin and Perfusion Index Levels
An observational study of Anemia and Delirium, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The overall aim of the study is to investigate the time difference in the diagnosing of anemia among elderly with hip fracture, between measurements with standard blood samples and non-invasive SpHb-measuring. Read more about this study
- Who is it for?
- Ages 65 years and older
- What is being tested?
- Surgery for hip fracture
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- May 2016to 1 Dec 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The subjects are patients age ≥ 65 years requiring surgery for a hip fracture.
Who may be able to join
- Age ≥ 65 years
- Primary hip fracture requiring surgery
- Patients able to give informed consent
- Patients who are able to undergo the Hospitals standardized fast track
- Perioperative care regimen for hip fracture including are pre operative placed epidural
Who cannot join
- Patients who can not co-operate to have a sensor attach to the finger continuous for 4 days.
- Patients who has allergy to the bandage that is used to attach the sensor.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen University Hospital Hvidovre, department of anesthesiology
Hvidovre, 2650
About this study
Official title: Contionuous Perioperative Hemoglobin and Perfusion Index Measurements in Elderly Patients With Hip Fracture and Post Operative Delirium
The overall aim of the study is to investigate the time difference in the diagnosing of anemia among elderly with hip fracture, between measurements with standard blood samples and non-invasive SpHb-measuring. Another aim is to investigate the relationship between perfusion index and prolong perioperative anemia and the potential impact on perioperative complications.
Read the detailed description
Immediately after admission and diagnosis of a hip fracture the patients will be monitored with Masimo SpHb. The Patients will be continuously measured until the third day after surgery. The Monitors Hb and PI data but not the SpO2% will be blinded to all participating healthcare personnel.The first three postopertive days the patiens will daily be examined to determined it they have developed delirium.
All perioperativ complications in that period will be monitored.
- Being tested
- Surgery for hip fracture
- Keywords
- postoperative anemia, perfusion index
- Medical subject headings
- Anemia, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery for hip fractureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Elderly with hip fracture | The subjects are patients age ≥ 65 years requiring surgery for a hip fracture Receives: Procedure: Surgery for hip fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay in diagnosting perioperative anemia
Description of lag time between detection of anaemia by SpHb and Hb by blood sampling/transfusion
Measured: From admission up to and including the 3 postopertive day
Perfusion index, periopertive anemia and delirium
The relation between average perioperative perfusion index, cumulated perioperative anemia over time and patient outcome in the form of medical complications, mortality, delirium and LOS.
Measured: From admission up to and including the 3 postopertive day
Secondary outcomes (1)
Perfusion index as a predictor of early warning score (EWS)
Is there a relationship between low perfusion index an high EWS?
Measured: From admission up to and including the 3 postopertive day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Clemmesen, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838706
- Sponsor's protocol ID
- HvidovreUH
- Status last verified
- Apr 2017
- First submitted
- 18 Apr 2016
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contionuous Perioperative Hemoglobin and Perfusion Index Measurements in Elderly Patients With Hip Fracture and Post Operative Delirium
- ClinicalTrials.gov ID
- NCT02838706
- Acronym / sponsor ID
- HvidovreUH
- Keywords
- postoperative anemia, perfusion index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 20 Jul 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.
The overall aim of the study is to investigate the time difference in the diagnosing of anemia among elderly with hip fracture, between measurements with standard blood samples and non-invasive SpHb-measuring. Another aim is to investigate the relationship between perfusion index and prolong perioperative anemia and the potential impact on perioperative complications.
Detailed description
Immediately after admission and diagnosis of a hip fracture the patients will be monitored with Masimo SpHb. The Patients will be continuously measured until the third day after surgery. The Monitors Hb and PI data but not the SpO2% will be blinded to all participating healthcare personnel.The first three postopertive days the patiens will daily be examined to determined it they have developed delirium.
All perioperativ complications in that period will be monitored.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly with hip fracture | – | Procedure: Surgery for hip fractureThe subjects are patients age ≥ 65 years requiring surgery for a hip fracture |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The subjects are patients age ≥ 65 years requiring surgery for a hip fracture.
Key inclusion criteria (5 listed)
- Age ≥ 65 years
- Primary hip fracture requiring surgery
- Patients able to give informed consent
- Patients who are able to undergo the Hospitals standardized fast track
- Perioperative care regimen for hip fracture including are pre operative placed epidural
Key exclusion criteria (2 listed)
- Patients who can not co-operate to have a sensor attach to the finger continuous for 4 days.
- Patients who has allergy to the bandage that is used to attach the sensor.
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 |
|---|---|---|
| Surgery for hip fracture | Procedure or surgery | Elderly with hip fracture |
Primary outcome
Delay in diagnosting perioperative anemia
Time frame: From admission up to and including the 3 postopertive day
Description of lag time between detection of anaemia by SpHb and Hb by blood sampling/transfusion
Perfusion index, periopertive anemia and delirium
Time frame: From admission up to and including the 3 postopertive day
The relation between average perioperative perfusion index, cumulated perioperative anemia over time and patient outcome in the form of medical complications, mortality, delirium and LOS.
1 secondary outcome
Perfusion index as a predictor of early warning score (EWS)
Time frame: From admission up to and including the 3 postopertive day
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 26 Apr 2017.
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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.
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 Anemia and Delirium, run by Hvidovre University Hospital at 1 site in Denmark.
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 5 inclusion and 2 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 26 Apr 2017. 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 Denmark. 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?
Delay in diagnosting perioperative anemia (time frame: From admission up to and including the 3 postopertive day). The study lists 2 primary outcomes in all. 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 2017.