Near-Infrared SpectroscopyNCT06773689
The Role of Near-infrared Spectroscopy Measurements in Determining İntraoperative Blood Loss in Cancer Surgery
An observational study of Near-Infrared Spectroscopy and Cancer Surgery, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital.
Trial summary
Major cancer surgeries often involve significant intraoperative blood loss and require transfusion. Conventional markers, such as hemoglobin (Hb) and hematocrit (Hct), provide limited insight into tissue oxygenation and transfusion thresholds. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Near-Infrared Spectroscopy, Cancer Surgery
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 30 Sep 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Sixty-five adult patients (aged 18-75 years) with American Society of Anesthesiologists (ASA) physical status I-III who were scheduled for major cancer surgery in the General Surgery, Urology, and Obstetrics and Gynecology departments
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I-III
- major cancer surgery in the General Surgery, Urology, and Obstetrics and Gynecology departments
Who cannot join
- carotid artery stenosis
- recent myocardial infarction
- history of cerebrovascular events
- prior neck surgery,
- cervical disc herniation
- spinal cord injury,
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- sudden vision loss,
- deep vein thrombosis,
- refusal to participate.
About this study
Official title: The Role of Cerebral and Peripheral Near-infrared Spectroscopy in Determining Intraoperative Blood Loss in Cancer Surgery
Major cancer surgeries often involve significant intraoperative blood loss and require transfusion. Conventional markers, such as hemoglobin (Hb) and hematocrit (Hct), provide limited insight into tissue oxygenation and transfusion thresholds. Near-infrared spectroscopy (NIRS) is a non-invasive approach for monitoring regional tissue oxygen saturation and guiding transfusion decisions. This study aimed to evaluate the role of cerebral (cSO₂) and peripheral (pSO₂) NIRS measurements in identifying intraoperative blood loss and determining transfusion thresholds during major cancer surgeries.
Read the detailed description
This prospective observational study included 65 patients aged 18-75 years who underwent major cancer surgery. cSO₂ and pSO₂ were monitored at three time points: baseline (T1), pre-transfusion or significant blood loss (T2), and the end of surgery (T3).Hemodynamic parameters, acid-base status, hemoglobin levels, estimated blood loss, and transfusion volumes were recorded.Patients were divided into transfused (group 1) and non-transfused (group 2) cohorts. Statistical analyses included t-tests, Mann-Whitney U tests, and receiver operating characteristic (ROC) analysis.
- Conditions
- Near-Infrared Spectroscopy, Cancer Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebral NIRS measurements
Near-infrared spectroscopy
Measured: T1 (Baseline): Before the start of surgery T2 (Pre-transfusion / Abundant bleeding): In the event of significant blood loss or just before transfusion T3 (At the end of surgery; assessed up to 5 minutes)
peripheral NIRS measurements
Near-infrared spectroscopy
Measured: T1 (Baseline): Before the start of surgery T2 (Pre-transfusion / Abundant bleeding): In the event of significant blood loss or just before transfusion T3 (At the end of surgery; assessed up to 5 minutes)
Secondary outcomes (3)
Hemoglobin
İntraoperative blood loss
Measured: T1 (Baseline): Before the start of surgery T2 (Pre-transfusion / Abundant bleeding): In the event of significant blood loss or just before transfusion T3 (At the end of surgery; assessed up to 5 minutes
Hematocrit
intraoperative blood loss
Measured: T1 (Baseline): Before the start of surgery T2 (Pre-transfusion / Abundant bleeding): In the event of significant blood loss or just before transfusion T3 (At the end of surgery; assessed up to 5 minutes
Estimated Blood Loss
intraoperative blood loss
Measured: T1 (Baseline): Before the start of surgery T2 (Pre-transfusion / Abundant bleeding): In the event of significant blood loss or just before transfusion T3 (At the end of surgery; assessed up to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start1 Jan 2015
- Primary completion1 May 2015
- Study completion30 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Near-Infrared SpectroscopyStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Sen, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773689
- Sponsor's protocol ID
- 2015-01/01
- Status last verified
- Jan 2025
- First submitted
- 3 Jan 2025
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Cerebral and Peripheral Near-infrared Spectroscopy in Determining Intraoperative Blood Loss in Cancer Surgery
- ClinicalTrials.gov ID
- NCT06773689
- Acronym / sponsor ID
- 2015-01/01
- Conditions
- Near-Infrared Spectroscopy, Cancer Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 May 2015 (actual)
- Study completion
- 30 Sep 2015 (actual)
- First posted
- 14 Jan 2025 (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.
Major cancer surgeries often involve significant intraoperative blood loss and require transfusion. Conventional markers, such as hemoglobin (Hb) and hematocrit (Hct), provide limited insight into tissue oxygenation and transfusion thresholds. Near-infrared spectroscopy (NIRS) is a non-invasive approach for monitoring regional tissue oxygen saturation and guiding transfusion decisions. This study aimed to evaluate the role of cerebral (cSO₂) and peripheral (pSO₂) NIRS measurements in identifying intraoperative blood loss and determining transfusion thresholds during major cancer surgeries.
Detailed description
This prospective observational study included 65 patients aged 18-75 years who underwent major cancer surgery. cSO₂ and pSO₂ were monitored at three time points: baseline (T1), pre-transfusion or significant blood loss (T2), and the end of surgery (T3).Hemodynamic parameters, acid-base status, hemoglobin levels, estimated blood loss, and transfusion volumes were recorded.Patients were divided into transfused (group 1) and non-transfused (group 2) cohorts. Statistical analyses included t-tests, Mann-Whitney U tests, and receiver operating characteristic (ROC) analysis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Sixty-five adult patients (aged 18-75 years) with American Society of Anesthesiologists (ASA) physical status I-III who were scheduled for major cancer surgery in the General Surgery, Urology, and Obstetrics and Gynecology departments
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status I-III
- major cancer surgery in the General Surgery, Urology, and Obstetrics and Gynecology departments
Key exclusion criteria (9 listed)
- carotid artery stenosis
- recent myocardial infarction
- history of cerebrovascular events
- prior neck surgery,
- cervical disc herniation
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
cerebral NIRS measurements
Time frame: T1 (Baseline): Before the start of surgery T2 (Pre-transfusion / Abundant bleeding): In the event of significant blood loss or just before transfusion T3 (At the end of surgery; assessed up to 5 minutes)
Near-infrared spectroscopy
peripheral NIRS measurements
Time frame: T1 (Baseline): Before the start of surgery T2 (Pre-transfusion / Abundant bleeding): In the event of significant blood loss or just before transfusion T3 (At the end of surgery; assessed up to 5 minutes)
Near-infrared spectroscopy
3 secondary outcomes
Hemoglobin
Time frame: T1 (Baseline): Before the start of surgery T2 (Pre-transfusion / Abundant bleeding): In the event of significant blood loss or just before transfusion T3 (At the end of surgery; assessed up to 5 minutes
Hematocrit
Time frame: T1 (Baseline): Before the start of surgery T2 (Pre-transfusion / Abundant bleeding): In the event of significant blood loss or just before transfusion T3 (At the end of surgery; assessed up to 5 minutes
Estimated Blood Loss
Time frame: T1 (Baseline): Before the start of surgery T2 (Pre-transfusion / Abundant bleeding): In the event of significant blood loss or just before transfusion T3 (At the end of surgery; assessed up to 5 minutes
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 14 Jan 2025.
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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 Near-Infrared Spectroscopy and Cancer Surgery, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital.
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 2 inclusion and 9 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 14 Jan 2025. 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?
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?
cerebral NIRS measurements (time frame: T1 (Baseline): Before the start of surgery T2 (Pre-transfusion / Abundant bleeding): In the event of significant blood loss or just before transfusion T3 (At the end of surgery; assessed up to 5 minutes)). 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 14 Jan 2025.