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Search / Trial NCT04155489

The Impact of Perioperative Transfusion on Postoperative Cognitive Dysfunction

Launched by GANGNAM SEVERANCE HOSPITAL · Nov 6, 2019

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of different blood transfusion strategies on older patients who undergo a specific type of back surgery called lumbar interbody fusion. Researchers want to find out if a more cautious approach, called "restrictive transfusion," which only gives blood when hemoglobin levels drop below 8 g/dL, can reduce the chances of postoperative cognitive dysfunction (POCD) compared to a "liberal transfusion" strategy, which starts transfusions at 10 g/dL. POCD can affect memory and thinking after surgery, and this study focuses on patients aged 65 and older, as they are more vulnerable to these issues.

To participate in the trial, patients must be 65 or older and scheduled for lumbar interbody fusion involving more than two levels. However, those with certain conditions, like severe anemia, mental health issues, or certain communication disorders, will not be eligible. Participants can expect to be monitored closely during and after their surgery to assess any changes in cognitive function. This study could help determine the best approach to blood transfusions in older adults to improve their recovery and overall health after surgery.

Gender

ALL

Eligibility 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

About Gangnam Severance Hospital

Gangnam Severance Hospital is a renowned medical institution located in Seoul, South Korea, dedicated to advancing healthcare through innovative research and clinical excellence. As a leading clinical trial sponsor, the hospital is committed to conducting cutting-edge research that enhances patient care and contributes to medical knowledge across various specialties. With a state-of-the-art facility and a multidisciplinary team of experienced researchers and healthcare professionals, Gangnam Severance Hospital prioritizes patient safety and ethical standards while striving to develop new treatments and therapies that address unmet medical needs. Through collaboration with academic institutions and industry partners, the hospital plays a pivotal role in shaping the future of medicine.

Locations

Seoul, , Korea, Republic Of

Patients applied

0 patients applied

Trial Officials

Yonhee Shim

Principal Investigator

Gangnam Severance Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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