POCDNCT04155489
The Impact of Perioperative Transfusion on Postoperative Cognitive Dysfunction
A study testing blood transfusion in people with POCD and Anemia, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- POCD, Anemia, Transfusion
- What is being tested?
- blood transfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Jan 2020to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients 65 years of age or older who receive more than two levels of lumbar interbody fusion
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gangnam Severance Hospital
Seoul, 06273
Hei jin Yoon, 82-2-2019-6689, PHIN86@yuhs.ac
About this study
Official title: The Impact of Perioperative Restrictive Transfusion on Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Spine Surgery
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.
Read more
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)
Read the 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
- Conditions
- POCD, Anemia, Transfusion
- Being tested
- blood transfusion
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood transfusionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: blood transfusion |
| Liberal | Experimental | In the liberal transfusion group, If the hemoglobin value is less than 10 g /dL, blood transfusions begin. Receives: Procedure: blood transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7th day after surgery (POD 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start8 Jan 2020
- Primary completion14 Oct 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for POCDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yon Hee Shim, Gangnam Severance Hospital
- Investigators
- Yonhee Shim, Principal investigator, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155489
- Sponsor's protocol ID
- 3-2019-0271
- Status last verified
- Aug 2023
- First submitted
- 5 Nov 2019
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23496244Chen 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.
PubMed 29848364Deiner 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.
PubMed 20007989Fan 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.
PubMed 24745810Fusaro 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.
PubMed 28019009Hudetz 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.
PubMed 21061037
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Perioperative Restrictive Transfusion on Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Spine Surgery
- ClinicalTrials.gov ID
- NCT04155489
- Acronym / sponsor ID
- 3-2019-0271
- Conditions
- POCD, Anemia, Transfusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 14 Oct 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 7 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| restrictive | Active comparator | Procedure: blood transfusionIn 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. |
| Liberal | Experimental | Procedure: blood transfusionIn the liberal transfusion group, If the hemoglobin value is less than 10 g /dL, blood transfusions begin. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients 65 years of age or older who receive more than two levels of lumbar interbody fusion
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood transfusionIn 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. | Procedure or surgery | Liberal, restrictive |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Background: PubMed 23496244Behrends 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.
- Background: PubMed 29848364Chen 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.
- Background: PubMed 20007989Deiner 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.
- Background: PubMed 24745810Fan 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.
- Background: PubMed 28019009Fusaro 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.
- Background: PubMed 21061037Hudetz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yonhee Shim principal investigator
Gangnam Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood transfusion in people with POCD and Anemia, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yonhee Shim (82-2-2019-3520, TREN125@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing the frequency of post-operative cognitive dysfunction diagnosed on the 7th day after surgery (time frame: 7th day after surgery (POD 7)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04155489, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.