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NCT Number: NCT06773689

The Role of Near-infrared Spectroscopy Measurements in Determining İntraoperative 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesiologists (ASA) physical status I-III
  • major cancer surgery in the General Surgery, Urology, and Obstetrics and Gynecology departments

Exclusion criteria

  • carotid artery stenosis
  • recent myocardial infarction
  • history of cerebrovascular events
  • prior neck surgery,
  • cervical disc herniation
  • spinal cord injury,
  • sudden vision loss,
  • deep vein thrombosis,
  • refusal to participate.

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

    İntraoperative blood loss

  2. 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

    intraoperative blood loss

  3. 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

    intraoperative blood loss

Sponsors and collaborators

Lead sponsor

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Other

Registry information

Official study title

The Role of Cerebral and Peripheral Near-infrared Spectroscopy in Determining Intraoperative Blood Loss in Cancer Surgery

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 14, 2025
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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