The Impact of Perioperative Transfusion on Postoperative Cognitive Dysfunction
Primary Purpose
POCD, Anemia, Transfusion
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
blood transfusion
Sponsored by
About this trial
This is an interventional prevention trial for POCD
Eligibility 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
Sites / Locations
- Gangnam Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
restrictive
Liberal
Arm 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.
In the liberal transfusion group, If the hemoglobin value is less than 10 g /dL, blood transfusions begin.
Outcomes
Primary Outcome Measures
Comparing the frequency of post-operative cognitive dysfunction diagnosed on the 7th day after surgery
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04155489
First Posted
November 5, 2019
Last Updated
August 7, 2023
Sponsor
Gangnam Severance Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04155489
Brief Title
The Impact of Perioperative Transfusion on Postoperative Cognitive Dysfunction
Official Title
The Impact of Perioperative Restrictive Transfusion on Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Spine Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 8, 2020 (Actual)
Primary Completion Date
October 14, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
POCD, Anemia, Transfusion
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
148 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
restrictive
Arm Type
Active Comparator
Arm 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.
Arm Title
Liberal
Arm Type
Experimental
Arm Description
In the liberal transfusion group, If the hemoglobin value is less than 10 g /dL, blood transfusions begin.
Intervention Type
Procedure
Intervention Name(s)
blood transfusion
Intervention 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. in the liberal transfusion group, If the hemoglobin value is less than 10 g /dL, blood transfusions begin.
Primary Outcome Measure Information:
Title
Comparing the frequency of post-operative cognitive dysfunction diagnosed on the 7th day after surgery
Description
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.
Time Frame
7th day after surgery (POD 7)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yonhee Shim
Phone
82-2-2019-3520
Email
TREN125@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yonhee Shim
Organizational Affiliation
Gangnam Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hei jin Yoon
Phone
82-2-2019-6689
Email
PHIN86@yuhs.ac
12. IPD Sharing Statement
Citations:
PubMed Identifier
23496244
Citation
Behrends M, DePalma G, Sands L, Leung J. Association between intraoperative blood transfusions and early postoperative delirium in older adults. J Am Geriatr Soc. 2013 Mar;61(3):365-70. doi: 10.1111/jgs.12143.
Results Reference
background
PubMed Identifier
29848364
Citation
Chen QH, Wang HL, Liu L, Shao J, Yu J, Zheng RQ. Effects of restrictive red blood cell transfusion on the prognoses of adult patients undergoing cardiac surgery: a meta-analysis of randomized controlled trials. Crit Care. 2018 May 31;22(1):142. doi: 10.1186/s13054-018-2062-5.
Results Reference
background
PubMed Identifier
20007989
Citation
Deiner S, Silverstein JH. Postoperative delirium and cognitive dysfunction. Br J Anaesth. 2009 Dec;103 Suppl 1(Suppl 1):i41-46. doi: 10.1093/bja/aep291.
Results Reference
background
PubMed Identifier
24745810
Citation
Fan YX, Liu FF, Jia M, Yang JJ, Shen JC, Zhu GM, Zhu SH, Li WY, Yang JJ, Ji MH. Comparison of restrictive and liberal transfusion strategy on postoperative delirium in aged patients following total hip replacement: a preliminary study. Arch Gerontol Geriatr. 2014 Jul-Aug;59(1):181-5. doi: 10.1016/j.archger.2014.03.009. Epub 2014 Mar 29.
Results Reference
background
PubMed Identifier
28019009
Citation
Fusaro MV, Nielsen ND, Nielsen A, Fontaine MJ, Hess JR, Reed RM, DeLisle S, Netzer G. Restrictive versus liberal red blood cell transfusion strategy after hip surgery: a decision model analysis of healthcare costs. Transfusion. 2017 Feb;57(2):357-366. doi: 10.1111/trf.13936. Epub 2016 Dec 26.
Results Reference
background
PubMed Identifier
21061037
Citation
Hudetz JA, Gandhi SD, Iqbal Z, Patterson KM, Pagel PS. Elevated postoperative inflammatory biomarkers are associated with short- and medium-term cognitive dysfunction after coronary artery surgery. J Anesth. 2011 Feb;25(1):1-9. doi: 10.1007/s00540-010-1042-y.
Results Reference
background
Learn more about this trial
The Impact of Perioperative Transfusion on Postoperative Cognitive Dysfunction
We'll reach out to this number within 24 hrs