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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elective Intracranial Craniotomy Patients | Adult patients undergoing elective intracranial craniotomy who are prospectively enrolled |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ji-Hoon Sim, MD | Contact | +82-2-3010-0586 | jihoon_sim@amc.seoul.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | Songpa | 05505 | South Korea |
No. Individual participant data will not be shared.
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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. | 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. | 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Up to postoperative day 30 |