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EPO for Postop Delirium in Elderly Patients

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Yonsei University

Status and phase

Completed
Phase 4

Conditions

Postoperative Delirium

Treatments

Drug: normal saline
Drug: Erythropoietin

Study type

Interventional

Funder types

Other

Identifiers

NCT06178835
4-2017-0694

Details and patient eligibility

About

Postoperative delirium is a common complication after surgery. The underlying pathophysiology of this complication is unclear, however neuroinflammation and oxidative stress secondary to surgery had shown to be the cause of postoperative cognitive dysfunction and delirium. Erythropoietin represents non-erythropoietic effects of anti-inflammatory properties. The aims of this study were to determine the role of erythropoietin toward the development of postoperative delirium, in terms of changes in inflammatory reaction by affecting the innate immunity in elderly patients undergoing total joint arthroplasty surgery.

Enrollment

76 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age 65 years and older
  • Patients scheduled for elective total knee arthroplasty, total hip arthroplasty

Exclusion criteria

  • Unable to communicate
  • Cognitive impairment
  • Unable to pre-screen delirium due to underlying central nervous system disease
  • History of hypersensitivity related to erythropoietin and other anesthesia-related drugs
  • History of myocardial infarction, pulmonary infarction, cerebral infarction, ischemic vascular disease, epilpesy, chronic liver disease, chronic kidney disease
  • Uncontrolled high blood pressure
  • Within one month of starting anti-hypertensive medication

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

76 participants in 2 patient groups, including a placebo group

Erythropoietin
Experimental group
Description:
500 IU/kg of EPO given intramuscularly 3 times for each patient
Treatment:
Drug: Erythropoietin
Control
Placebo Comparator group
Description:
Same amount of normal saline given intramuscularly 3 times for each patient
Treatment:
Drug: normal saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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