Clinical trial NCT04155489: 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
Overall status: RECRUITING
Phase: NA
Conditions: POCD
Anemia
Transfusion
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2019-11-07
Enrollment: 148
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Comparing the frequency of post-operative cognitive dysfunction diagnosed on the 7th day after surgery
timeFrame: 7th day after surgery (POD 7)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
affiliation: Gangnam Severance Hospital
name: Yonhee Shim
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.