AnemiaNCT03328780
Anemia in Orthopedic Surgery - Determination of Hb
An observational study of Anemia, run by Theusinger Oliver M. at 1 site in Switzerland.
Trial summary
Anemia prevalence in orthopedic surgery is up to 30 %. Identifying those patients prior to surgery and treating them would be ideal. Different ways of determining hemoglobin Levels are available. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- Hemocue and Rad-67 measurement
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteSwitzerland
- Study dates
- 18 Dec 2017to 21 Feb 2018
- How long will I take part?
- 1 Day
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients scheduled for elective orthopedic surgery.
Who may be able to join
- Age > 18 years
- Scheduled for elective orthopedic surgery
- Written informed consent.
Who cannot join
- Not able to speak the german language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Anemia in Orthopedic Surgery, Data Collection From Classical Laboratory Determination of Hemoglobin, by Non-invasive Hemoglobin Measurement (Rad-67™) and by HemoCue®.
Anemia prevalence in orthopedic surgery is up to 30 %. Identifying those patients prior to surgery and treating them would be ideal. Different ways of determining hemoglobin Levels are available. In this study classical laboratory determination, determination with HemoCue® and Rad-67™ will be performed to compare precision of those three methods as well as their correlation.
- Conditions
- Anemia
- Being tested
- Hemocue and Rad-67 measurement
- Keywords
- preoperative, orthopedic surgery
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemocue and Rad-67 measurementDevice
Measurement of the hemoglobin level
| Study group | Role | What they receive |
|---|---|---|
| Hemoglobin determination | In this study classical laboratory determination, determination with HemoCue® and Rad-67™ will be performed to compare precision of those three methods as well as their correlation. Receives: Device: Hemocue and Rad-67 measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Precision
Precision of the Masimo Rad-67 versus standard hemoglobin determination in the laboratory and the Hemocue (Correlation, Standard deviation, possible significant differences).
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Anemia
Prevalence of anemia in elective orthopedic surgery
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start18 Dec 2017
- Primary completion21 Feb 2018
- Study completion21 Feb 2018
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
- 300 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Theusinger Oliver M.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Theusinger Oliver M., Balgrist University Hospital
- Investigators
- Oliver M Theusinger, MD, Study director, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328780
- Sponsor's protocol ID
- BASEC-Nr:2017-01361
- Status last verified
- Jan 2018
- First submitted
- 26 Oct 2017
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Anemia in Orthopedic Surgery, Data Collection From Classical Laboratory Determination of Hemoglobin, by Non-invasive Hemoglobin Measurement (Rad-67™) and by HemoCue®.
- ClinicalTrials.gov ID
- NCT03328780
- Acronym / sponsor ID
- BASEC-Nr:2017-01361
- Conditions
- Anemia
- Keywords
- preoperative, orthopedic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Theusinger Oliver M.University, hospital or other
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 21 Feb 2018 (actual)
- Study completion
- 21 Feb 2018 (actual)
- First posted
- 1 Nov 2017 (actual)
- 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.
Anemia prevalence in orthopedic surgery is up to 30 %. Identifying those patients prior to surgery and treating them would be ideal. Different ways of determining hemoglobin Levels are available. In this study classical laboratory determination, determination with HemoCue® and Rad-67™ will be performed to compare precision of those three methods as well as their correlation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemoglobin determination | – | Device: Hemocue and Rad-67 measurementIn this study classical laboratory determination, determination with HemoCue® and Rad-67™ will be performed to compare precision of those three methods as well as their correlation. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients scheduled for elective orthopedic surgery.
Key inclusion criteria (3 listed)
- Age > 18 years
- Scheduled for elective orthopedic surgery
- Written informed consent.
Key exclusion criteria (1 listed)
- Not able to speak the german language
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 |
|---|---|---|
| Hemocue and Rad-67 measurementMeasurement of the hemoglobin level | Device | Hemoglobin determination |
Primary outcome
Precision
Time frame: through study completion, an average of 1 year
Precision of the Masimo Rad-67 versus standard hemoglobin determination in the laboratory and the Hemocue (Correlation, Standard deviation, possible significant differences).
1 secondary outcome
Anemia
Time frame: through study completion, an average of 1 year
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 23 Feb 2018.
- Individual participant dataSharing planned: No
Related trials for Anemia
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
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.
Oliver M Theusinger, MD study director
Balgrist University Hospital
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, run by Theusinger Oliver M. at 1 site in Switzerland.
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 3 inclusion and 1 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 23 Feb 2018. 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 Switzerland. 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?
Precision (time frame: through study completion, an average of 1 year). 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 23 Feb 2018.