Blood Viscosity and Outcomes After Elective Craniotomy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorAsan Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Emergency surgery
Patients in whom participation or follow-up is considered difficult by the investigator
Patients unable to provide informed consent
Trial population
Adult patients undergoing elective intracranial craniotomy at a single tertiary care center will be prospectively enrolled. All eligible patients will be consecutively included during the study period. The study population represents patients undergoing various types of intracranial surgery, including tumor resection and aneurysm clipping, managed according to standard clinical practice.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Observational Assessment of Blood Viscosity
Other interventionNo intervention is assigned. Intraoperative blood viscosity and clinical variables are measured as part of routine care and analyzed for association with postoperative outcomes.
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Elective Intracranial Craniotomy Patients1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with one or more postoperative composite complications within 30 days after surgery
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.
Time frame
Up to postoperative day 30Secondary outcomes
1
Change in high-shear blood viscosity from after induction of anesthesia to 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.
Time frame
After induction of anesthesia and near the end of surgery2
Change in low-shear blood viscosity from after induction of anesthesia to 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.
Time frame
After induction of anesthesia and near the end of surgery3
Change in TODI from after induction of anesthesia to 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.
Time frame
After induction of anesthesia and near the end of surgery4
Intraoperative regional cerebral oxygen saturation desaturation burden
Cumulative burden of intraoperative regional cerebral oxygen saturation below the predefined study threshold during surgery.
Time frame
From after induction of anesthesia to end of surgerySponsors and contacts
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Source ClinicalTrials.gov