Anemia, POCD, Transfusion
Conditions
Brief 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
Interventions
PROCEDUREblood transfusion
In 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.
Sponsors
Gangnam Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparing the frequency of post-operative cognitive dysfunction diagnosed on the 7th day after surgery | 7th day after surgery (POD 7) | On the day before the surgery and the seventh day after the surgery, the patient scan K-MOCA (Korean-Montreal Cognitive Assessment). If the difference between the preoperative test results and the post-operative test results is RCI (Reliable Change Index) \<-1.96, it is determined that cognitive dysfunction occurred. |
Countries
South Korea
Contacts
Primary ContactYonhee Shim
Outcome results
None listed