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Not yet recruiting NCT07530393

Blood Viscosity and Outcomes After Elective Craniotomy

— Observational Postoperative Complications Intracranial Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observational Assessment of Blood Viscosity.
Who it may be relevant to
Registry conditions: Postoperative Complications, Intracranial Surgery. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other Observational Assessment of Blood Viscosity
    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 outcome measures

  • Number of participants with one or more postoperative composite complications within 30 days after surgery [Time frame: Up to postoperative day 30]
Secondary outcome measures (12)
  • 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]
  • 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]
  • 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]
  • Intraoperative regional cerebral oxygen saturation desaturation burden [Time frame: From after induction of anesthesia to end of surgery]
  • Area under the predefined regional cerebral oxygen saturation desaturation threshold curve during surgery [Time frame: From after induction of anesthesia to end of surgery]
  • Number of participants with postoperative neurologic complications within 30 days after surgery [Time frame: Up to postoperative day 30]
  • Number of participants with postoperative respiratory complications within 30 days after surgery [Time frame: Up to postoperative day 30]
  • Number of participants with postoperative cardiovascular complications within 30 days after surgery [Time frame: Up to postoperative day 30]
  • Number of participants with acute kidney injury within 30 days after surgery [Time frame: Up to postoperative day 30]
  • Number of participants with postoperative infectious complications within 30 days after surgery [Time frame: Up to postoperative day 30]
  • Number of participants requiring reoperation or major postoperative intervention within 30 days after surgery [Time frame: Up to postoperative day 30]
  • Number of participants with all-cause mortality within 30 days after surgery [Time frame: Up to postoperative day 30]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Asan Medical Center — Seoul

Identifiers

NCT: NCT07530393 · AMC (2026-0404)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗