An observational study in Postoperative Complications and Intracranial Surgery, sponsored by Asan Medical Center. Recruiting at 1 site in South Korea. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Asan Medical Center · Observational
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.
1,332 studies on the registry are indexed under Postoperative Complications; 311 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 251 across 537 observational studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Asan Medical Center is the lead sponsor of 578 studies on the registry; 73 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients undergoing elective intracranial craniotomy who are prospectively enrolled
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.
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 30
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 surgery
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 surgery
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 surgery
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 surgery
Area under the predefined regional cerebral oxygen saturation desaturation threshold curve during surgery
Area under the predefined desaturation threshold curve for regional cerebral oxygen saturation 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
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.
Time frame: Up to postoperative day 30
Number of participants with postoperative respiratory complications within 30 days after surgery
Postoperative respiratory complications include pneumonia, reintubation, mechanical ventilation for more than 24 hours after surgery, pulmonary edema, or respiratory failure requiring treatment.
Time frame: Up to postoperative day 30
Number of participants with postoperative cardiovascular complications within 30 days after surgery
Postoperative cardiovascular complications include myocardial infarction, new arrhythmia requiring treatment, or other clinically significant circulatory complications.
Time frame: Up to postoperative day 30
Number of participants with acute kidney injury within 30 days after surgery
Acute kidney injury is defined as Kidney Disease Improving Global Outcomes stage 1 or higher within 30 days after surgery.
Time frame: Up to postoperative day 30
Number of participants with postoperative infectious complications within 30 days after surgery
Postoperative infectious complications are defined as infections requiring intravenous antibiotics or a procedure 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
Reoperation or major postoperative intervention occurring within 30 days after surgery.
Time frame: Up to postoperative day 30
Number of participants with all-cause mortality within 30 days after surgery
All-cause death occurring within 30 days after surgery.
Time frame: Up to postoperative day 30
Plan to share: No — No. Individual participant data will not be shared.
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Dec 2029, 42 months after the start.
Of 276 non-industry observational studies under Postoperative Complications, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 42 months is above that.
Counting every sponsor, half of 281 studies reached it within 23 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.