Evaluating the effects of blood transfusion policies on cognitive function after surgery
The Impact of Perioperative Restrictive Transfusion on Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Spine Surgery
This study is testing whether using less blood during surgery helps older patients avoid problems with thinking and memory after their operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Ages | 65 Years to 100 Years |
| Sex | All |
| Sponsor | Gangnam Severance Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT04155489 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of restrictive versus liberal blood transfusion policies on the incidence of postoperative cognitive dysfunction in patients aged 65 and older undergoing lumbar interbody fusion. It aims to determine if a restrictive transfusion approach, which conserves blood resources, can reduce cognitive impairment compared to a more liberal approach. The study will assess cognitive function using the K-MOCA test and measure inflammatory markers to explore their relationship with cognitive outcomes. By comparing these two transfusion strategies, the research seeks to clarify the optimal approach for managing anemia in elderly surgical patients.
Who should consider this trial
Good fit: Ideal candidates are patients aged 65 years or older who are scheduled for lumbar interbody fusion and do not have significant anemia.
Not a fit: Patients with severe anemia, communication disorders, or those requiring emergency surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cognitive outcomes for elderly patients undergoing surgery.
How similar studies have performed: Previous studies have shown mixed results regarding transfusion strategies and cognitive outcomes, making this approach both relevant and necessary for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients 65 years of age or older who receive more than two levels of lumbar interbody fusion Exclusion Criteria: * If patients have anemia (Hb is less than 13 g / dL for men and less than 12 g / dL for women) * Those who cannot read the agreement (illiteracy, foreigner, etc.) * Have a history of taking medication for mental illness * Communication disorders due to neurological diseases (dementia, stroke, seizures, etc.) * Less than 23 points on K-MoCA test * When fluid loading and volulyte are difficult due to kidney disease * Limited blood transfusion due to heart disease * Refusal of blood transfusions (religious reasons, etc.) * patients who have received a blood transfusion within 6 weeks prior to surgery * If continuous observation is impossible after surgery * Emergency surgery
Where this trial is running
Seoul
- Gangnam Severance Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Yonhee Shim — Gangnam Severance Hospital
- Study coordinator: Yonhee Shim
- Email: TREN125@yuhs.ac
- Phone: 82-2-2019-3520
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.