Clinical Trials Directory

Trials / Unknown

UnknownNCT04155489

The Impact of Perioperative Transfusion on Postoperative Cognitive Dysfunction

The Impact of Perioperative Restrictive Transfusion on Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Spine Surgery

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
148 (estimated)
Sponsor
Gangnam Severance Hospital · Academic / Other
Sex
All
Age
65 Years – 100 Years
Healthy volunteers
Not accepted

Summary

Although blood transfusion is a representative treatment for acute anemia due to blood loss during surgery, it is also a powerful risk factor for postoperative cognitive dysfunction. 'Restrictive transfusion', which transfusions minimal red blood cells, is not only useful for conserving limited blood resources, but also does not worsen prognosis or mortality after surgery. Research has also been reported that severe restrictive transfusion has improved prognosis and mortality. However, anemia is also one of the risk factors for postoperative complications, including neurocognitive impairment, it is still controversial how much anemia should be allowed in elderly people who are sensitive to ischemia or heart disease. The purpose of this study is to determine whether the restrictive transfusion policy reduces the frequency of postoperative cognitive dysfunction than the liberal transfusion policy in patients aged 65 years or older who undergo lumbar interbody fusion. Restrictive transfusion strategy (which initiates transfusion when hemoglobin level is less than 8 g / dL during perioperative period) // liberal transfusion strategy (which initiates transfusion when hemoglobin level is less than 10 g / dL during perioperative period)

Detailed description

The Aim of this study was to compare the frequency of postoperative cognitive dysfunction diagnosed 7 days after surgery between two groups. K-MOCA (Korean-Montreal Cognitive Assessment) is used to evaluate cognitive dysfunction. In addition, plasma inflammatory markers (CRP, IL-6) and GFAP reflecting brain damage were measured before and after surgery to determine whether brain injury caused by systemic inflammatory response is associated with cognitive dysfunction

Conditions

Interventions

TypeNameDescription
PROCEDUREblood transfusionIn the restrictive blood transfusion group, if the hemoglobin value is less than 8 g /dL or if there are suspected symptoms of anemia such as dizziness or chest pain, headache, low on energy, blood transfusion is started. in the liberal transfusion group, If the hemoglobin value is less than 10 g /dL, blood transfusions begin.

Timeline

Start date
2020-01-08
Primary completion
2024-10-14
Completion
2024-10-31
First posted
2019-11-07
Last updated
2023-08-09

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT04155489. Inclusion in this directory is not an endorsement.