NCT04155489

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 8, 2020

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2024

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

August 9, 2023

Status Verified

August 1, 2023

Enrollment Period

4.8 years

First QC Date

November 5, 2019

Last Update Submit

August 7, 2023

Conditions

POCDAnemiaTransfusion

Outcome Measures

Primary Outcomes (1)

  • 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.

    7th day after surgery (POD 7)

Study Arms (2)

restrictive

ACTIVE COMPARATOR

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

Liberal

EXPERIMENTAL

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

Procedure: blood transfusion

Interventions

blood transfusionPROCEDURE

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.

Liberalrestrictive

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients 65 years of age or older who receive more than two levels of lumbar interbody fusion

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam Severance Hospital

Seoul, 06273, South Korea

RECRUITING

Related Publications (6)

  • 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.

    PMID: 23496244BACKGROUND

  • 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.

    PMID: 29848364BACKGROUND

  • 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.

    PMID: 20007989BACKGROUND

  • 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.

    PMID: 24745810BACKGROUND

  • 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.

    PMID: 28019009BACKGROUND

  • 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.

    PMID: 21061037BACKGROUND

MeSH Terms

Conditions

Anemia

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Yonhee Shim

    Gangnam Severance Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yonhee Shim

CONTACT

82-2-2019-3520TREN125@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor,Department of Anesthesiology and Pain Medicine

Study Record Dates

First Submitted

November 5, 2019

First Posted

November 7, 2019

Study Start

January 8, 2020

Primary Completion

October 14, 2024

Study Completion

October 31, 2024

Last Updated

August 9, 2023

Record last verified: 2023-08

Locations

KR(1)