BleedingNCT04785274
The Effect of Non-invasive Hemoglobin Measurement in Hip Surgeries
An observational study of Bleeding and Hemorrhage, run by Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
Bleeding is one of the most important causes of mortality and morbidity in patients. Hb levels are the most prevalently utilized monitoring parameter in hemorrhagic patients in the hemodynamic sense. Hemoglobin determination is studied at laboratories along with blood gasses or complete blood analysis. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bleeding, Hemorrhage, Hemodynamic Instability
- What is being tested?
- non-invasive hemoglobin (SpHb)
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 31 Dec 2021
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: General anesthesia undergoing hip surgery
Who may be able to join
- 18-60 years old
- General anesthesia undergoing hip surgery
- American society of anesthesiology (ASA) scores I-II-III
Who cannot join
- Receiving inotropic support
- Uncontrolled diabetes
- Arrhythmia
- Hypothermia
- Hyperbilirubinemia
- Jaundice
Show all 12Show fewer
- Dark skin pigmentation
- Without voluntary consent
- Hypovolemia,
- hypotension,
- sepsis,
- blood diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bulent Ecevit University Medicine Faculty
Zonguldak, 67600
About this study
Official title: The Effect of Non-invasive Hemoglobin Measurement on Blood Transfusion and Mortality in Hip Surgeries: a Randomized Controlled Trial
Bleeding is one of the most important causes of mortality and morbidity in patients.
Hb levels are the most prevalently utilized monitoring parameter in hemorrhagic patients in the hemodynamic sense. Hemoglobin determination is studied at laboratories along with blood gasses or complete blood analysis. Recently, non-invasive techniques where measurement is made from the fingertips have been offered for use. One of these techniques is non-invasive hemoglobin (SpHb) measurement. SpHb is used as a trend monitor. Based on the severity of bleeding, the compensatory mechanisms of patients may be disrupted. This situation may lead to lower levels of toleration of anemia during bleeding. The relationship between blood transfusion and mortality is under debate.
- Conditions
- Bleeding, Hemorrhage, Hemodynamic Instability
- Being tested
- non-invasive hemoglobin (SpHb)
- Keywords
- Perioperative Bleeding, Mortality, Hemoglobin, Non-invasive monitoring, Transfusion;, SpHb
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive hemoglobin (SpHb)Device
hemoglobin measuring device
| Study group | Role | What they receive |
|---|---|---|
| SpHb | Not described Receives: Device: non-invasive hemoglobin (SpHb) | |
| Control | Not described Receives: Device: non-invasive hemoglobin (SpHb) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic Stability
to compare blood transfusion decisions made with SpHb measurement values and with conventional methods in patient who would receive hip surgery.
Measured: during the surgery
Secondary outcomes (1)
Mortality
to compare the effects of transfusion results on mortality.
Measured: until 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, OZCAN PISKIN, MD, Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785274
- Sponsor's protocol ID
- 2020-24/16/12/2020
- Status last verified
- Aug 2022
- First submitted
- 3 Mar 2021
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Non-invasive Hemoglobin Measurement on Blood Transfusion and Mortality in Hip Surgeries: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04785274
- Acronym / sponsor ID
- 2020-24/16/12/2020
- Conditions
- Bleeding, Hemorrhage, Hemodynamic Instability
- Keywords
- Perioperative Bleeding, Mortality, Hemoglobin, Non-invasive monitoring, Transfusion;, SpHb
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 5 Mar 2021 (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.
Bleeding is one of the most important causes of mortality and morbidity in patients.
Hb levels are the most prevalently utilized monitoring parameter in hemorrhagic patients in the hemodynamic sense. Hemoglobin determination is studied at laboratories along with blood gasses or complete blood analysis. Recently, non-invasive techniques where measurement is made from the fingertips have been offered for use. One of these techniques is non-invasive hemoglobin (SpHb) measurement. SpHb is used as a trend monitor. Based on the severity of bleeding, the compensatory mechanisms of patients may be disrupted. This situation may lead to lower levels of toleration of anemia during bleeding. The relationship between blood transfusion and mortality is under debate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SpHb | – | Device: non-invasive hemoglobin (SpHb) |
| Control | – | Device: non-invasive hemoglobin (SpHb) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- General anesthesia undergoing hip surgery
Key inclusion criteria (3 listed)
- 18-60 years old
- General anesthesia undergoing hip surgery
- American society of anesthesiology (ASA) scores I-II-III
Key exclusion criteria (12 listed)
- Receiving inotropic support
- Uncontrolled diabetes
- Arrhythmia
- Hypothermia
- Hyperbilirubinemia
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 |
|---|---|---|
| non-invasive hemoglobin (SpHb)hemoglobin measuring device | Device | Control, SpHb |
Primary outcome
Hemodynamic Stability
Time frame: during the surgery
to compare blood transfusion decisions made with SpHb measurement values and with conventional methods in patient who would receive hip surgery.
1 secondary outcome
Mortality
Time frame: until 3 months after surgery
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 Aug 2022.
- 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.
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 Bleeding and Hemorrhage, run by Bulent Ecevit University at 1 site in Turkey (Türkiye).
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 12 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 Aug 2022. 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 Turkey (Türkiye). 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?
Hemodynamic Stability (time frame: during the surgery). 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 Aug 2022.