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NCT Number: NCT07530393

Blood Viscosity and Outcomes After Elective Craniotomy

This prospective observational study aims to evaluate the association between intraoperative blood viscosity and postoperative clinical outcomes in adult patients undergoing elective intracranial craniotomy.

Blood viscosity is an important determinant of microcirculatory flow and cerebral perfusion, but its role in perioperative outcomes remains unclear. In this study, intraoperative blood viscosity and related hematologic parameters will be measured, and their relationships with cerebral oxygenation and postoperative complications will be analyzed.

The study will enroll adult patients undergoing elective intracranial surgery at a single tertiary center. The findings of this study may improve understanding of perioperative hemodynamic and hemorheological factors and help identify potential risk markers for adverse postoperative outcomes.

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Key information

Conditions

Postoperative Complications Intracranial Surgery Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults aged 18 to 80 years
  • Patients scheduled to undergo elective intracranial craniotomy
  • Patients requiring intraoperative arterial catheterization and routine arterial blood gas analysis
  • Patients who provide written informed consent

Exclusion criteria

  • Emergency surgery
  • Patients in whom participation or follow-up is considered difficult by the investigator
  • Patients unable to provide informed consent

Treatment and study plan

Observational Assessment of Blood Viscosity

Other

No intervention is assigned. Intraoperative blood viscosity and clinical variables are measured as part of routine care and analyzed for association with postoperative outcomes.

Primary outcomes

  1. Number of participants with one or more postoperative composite complications within 30 days after surgery

    Time frame: Up to postoperative day 30

    Composite complication is defined as the occurrence of at least one of the following within 30 days after surgery: postoperative neurologic complications, respiratory complications, cardiovascular complications, acute kidney injury defined as Kidney Disease Improving Global Outcomes stage 1 or higher, infectious complications requiring intravenous antibiotics or a procedure, reoperation or major postoperative intervention, or death.

Secondary outcomes

  1. Change in high-shear blood viscosity from after induction of anesthesia to near the end of surgery

    Time frame: After induction of anesthesia and near the end of surgery

    High-shear blood viscosity will be measured at the first protocol-specified intraoperative blood sampling time point after induction of anesthesia and arterial line placement and at the second protocol-specified time point near the end of surgery. The reported value will be the change between the two measurements.

  2. Change in low-shear blood viscosity from after induction of anesthesia to near the end of surgery

    Time frame: After induction of anesthesia and near the end of surgery

    Low-shear blood viscosity will be measured at the first protocol-specified intraoperative blood sampling time point after induction of anesthesia and arterial line placement and at the second protocol-specified time point near the end of surgery. The reported value will be the change between the two measurements.

  3. Change in TODI from after induction of anesthesia to near the end of surgery

    Time frame: After induction of anesthesia and near the end of surgery

    TODI will be measured or calculated at the first protocol-specified intraoperative blood sampling time point after induction of anesthesia and arterial line placement and at the second protocol-specified time point near the end of surgery. The reported value will be the change between the two measurements.

  4. Intraoperative regional cerebral oxygen saturation desaturation burden

    Time frame: From after induction of anesthesia to end of surgery

    Cumulative burden of intraoperative regional cerebral oxygen saturation below the predefined study threshold during surgery.

  5. Area under the predefined regional cerebral oxygen saturation desaturation threshold curve during surgery

    Time frame: From after induction of anesthesia to end of surgery

    Area under the predefined desaturation threshold curve for regional cerebral oxygen saturation during surgery

  6. Number of participants with postoperative neurologic complications within 30 days after surgery

    Time frame: Up to postoperative day 30

    Postoperative neurologic complications include new or worsened focal neurologic deficit, postoperative cerebral infarction, postoperative intracranial hemorrhage, clinically significant cerebral edema, seizure requiring treatment, or decreased consciousness or delayed emergence requiring imaging or additional intervention.

  7. Number of participants with postoperative respiratory complications within 30 days after surgery

    Time frame: Up to postoperative day 30

    Postoperative respiratory complications include pneumonia, reintubation, mechanical ventilation for more than 24 hours after surgery, pulmonary edema, or respiratory failure requiring treatment.

  8. Number of participants with postoperative cardiovascular complications within 30 days after surgery

    Time frame: Up to postoperative day 30

    Postoperative cardiovascular complications include myocardial infarction, new arrhythmia requiring treatment, or other clinically significant circulatory complications.

  9. Number of participants with acute kidney injury within 30 days after surgery

    Time frame: Up to postoperative day 30

    Acute kidney injury is defined as Kidney Disease Improving Global Outcomes stage 1 or higher within 30 days after surgery.

  10. Number of participants with postoperative infectious complications within 30 days after surgery

    Time frame: Up to postoperative day 30

    Postoperative infectious complications are defined as infections requiring intravenous antibiotics or a procedure within 30 days after surgery.

  11. Number of participants requiring reoperation or major postoperative intervention within 30 days after surgery

    Time frame: Up to postoperative day 30

    Reoperation or major postoperative intervention occurring within 30 days after surgery.

  12. Number of participants with all-cause mortality within 30 days after surgery

    Time frame: Up to postoperative day 30

    All-cause death occurring within 30 days after surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Ji-Hoon Sim, MD

CONTACT

[email protected]

+82-2-3010-0586

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

Association of Intraoperative Blood Viscosity With Cerebral Oxygenation and Postoperative Composite Complications in Adults Undergoing Elective Intracranial Craniotomy: A Prospective Observational Study

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

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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