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The Impact of Perioperative Transfusion on Postoperative Cognitive Dysfunction

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ClinicalTrials.gov Identifier: NCT04155489
Recruitment Status : Not yet recruiting
First Posted : November 7, 2019
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Yon Hee Shim, 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)


Condition or disease Intervention/treatment Phase
POCD Anemia Transfusion Procedure: blood transfusion Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Impact of Perioperative Restrictive Transfusion on Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Spine Surgery
Estimated Study Start Date : December 15, 2019
Estimated Primary Completion Date : October 14, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: restrictive
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.
Procedure: blood 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.

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




Primary Outcome Measures :
  1. Comparing the frequency of post-operative cognitive dysfunction diagnosed on the 7th day after surgery [ Time Frame: 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.



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Ages Eligible for Study:   65 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Publications:

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Responsible Party: Yon Hee Shim, Professor,Department of Anesthesiology and Pain Medicine, Gangnam Severance Hospital
ClinicalTrials.gov Identifier: NCT04155489    
Other Study ID Numbers: 3-2019-0271
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders