The Impact of Perioperative Transfusion on Postoperative Cognitive Dysfunction

Yonsei University Health System (YUHS)

Status: Enrolling

Conditions: Anemia; POCD; Transfusion

Treatments: Procedure: blood transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT04155489

3-2019-0271

Details and patient eligibility

About

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)

Full 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

Enrollment: 148 estimated patients

Sex: All

Ages: 65 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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148 participants in 2 patient groups

restrictive

Active Comparator group

Description:

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.

Treatment:

Procedure: blood transfusion

Liberal

Experimental group

Description:

In the liberal transfusion group, If the hemoglobin value is less than 10 g /dL, blood transfusions begin.

Treatment:

Procedure: blood transfusion