The Impact of Perioperative Transfusion on Postoperative Cognitive Dysfunction

Not Applicable

Recruiting

• Conditions: POCD; Transfusion; Anemia

• Registration Number: NCT04155489
• Lead Sponsor: Gangnam Severance Hospital

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

Study Timeline

• Study First Submitted: 2019-11-05
• Study First Submitted QC: 2019-11-06
• Study First Posted: 2019-11-07
• Study Start: 2020-01-08
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-09
• Primary Completion: 2024-10-14
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of