Blood Viscosity and Outcomes After Elective Craniotomy

NCT07530393 | Not Yet Recruiting

• 1 other identifier: AMC (2026-0404)
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Complications; Intracranial Surgery

Keywords

blood viscosity; intracranial craniotomy; neurosurgery; cerebral oxygenation; postoperative complications; hemodynamics

Outcome Measures

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.

  Up to postoperative day 30

Secondary Outcomes (12)

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

  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

  After induction of anesthesia and near the end of surgery

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

  After induction of anesthesia and near the end of surgery

• Intraoperative regional cerebral oxygen saturation desaturation burden

  From after induction of anesthesia to end of surgery

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

  From after induction of anesthesia to end of surgery

Study Arms (1)

Elective Intracranial Craniotomy Patients

Adult patients undergoing elective intracranial craniotomy who are prospectively enrolled

Other: Observational Assessment of Blood Viscosity

Interventions

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.

Elective Intracranial Craniotomy Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, Songpa, 05505, South Korea

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ji-Hoon Sim, MD

CONTACT

+82-2-3010-0586; jihoon_sim@amc.seoul.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 15, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): March 31, 2030
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)