Postoperative ComplicationsNCT07530393
Blood Viscosity and Outcomes After Elective Craniotomy
An observational study of Postoperative Complications and Intracranial Surgery, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Complications, Intracranial Surgery
- What is being tested?
- Observational Assessment of Blood Viscosity
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Jun 2026to 31 Mar 2030
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Emergency surgery
- Patients in whom participation or follow-up is considered difficult by the investigator
- Patients unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, Songpa, 05505
Ji-Hoon Sim, MD, +82-10-9237-2778, jihoon_sim@amc.seoul.kr
About this study
Official title: Association of Intraoperative Blood Viscosity With Cerebral Oxygenation and Postoperative Composite Complications in Adults Undergoing Elective Intracranial Craniotomy: A Prospective Observational Study
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
- Being tested
- Observational Assessment of Blood Viscosity
- Keywords
- blood viscosity, intracranial craniotomy, neurosurgery, cerebral oxygenation, postoperative complications, hemodynamics
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational Assessment of Blood ViscosityOther
No intervention is assigned. Intraoperative blood viscosity and clinical variables are measured as part of routine care and analyzed for association with postoperative outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Elective Intracranial Craniotomy Patients | Adult patients undergoing elective intracranial craniotomy who are prospectively enrolled Receives: Other: Observational Assessment of Blood Viscosity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to postoperative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start23 Jun 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Hoon Sim, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530393
- Sponsor's protocol ID
- AMC (2026-0404)
- Status last verified
- Sep 2026
- First submitted
- 31 Mar 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No. Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Intraoperative Blood Viscosity With Cerebral Oxygenation and Postoperative Composite Complications in Adults Undergoing Elective Intracranial Craniotomy: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07530393
- Acronym / sponsor ID
- AMC (2026-0404)
- Conditions
- Postoperative Complications, Intracranial Surgery
- Keywords
- blood viscosity, intracranial craniotomy, neurosurgery, cerebral oxygenation, postoperative complications, hemodynamics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 23 Jun 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective Intracranial Craniotomy Patients | – | Other: Observational Assessment of Blood ViscosityAdult patients undergoing elective intracranial craniotomy who are prospectively enrolled |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Emergency surgery
- Patients in whom participation or follow-up is considered difficult by the investigator
- Patients unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational Assessment of Blood ViscosityNo intervention is assigned. Intraoperative blood viscosity and clinical variables are measured as part of routine care and analyzed for association with postoperative outcomes. | Other | Elective Intracranial Craniotomy Patients |
Primary outcome
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.
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No. No. Individual participant data will not be shared.
Related trials for Postoperative Complications
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Recruiting
Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
Chronic Post-surgical Pain, Chronic Post Operative Pain
Recruiting
Lateral QL Block vs Intrathecal Morphine for Cesarean Section
Anesthesia, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications and Intracranial Surgery, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ji-Hoon Sim, MD (+82-2-3010-0586, jihoon_sim@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with one or more postoperative composite complications within 30 days after surgery (time frame: Up to postoperative day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.