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Intravenous Iron Supplement to Prevent Postoperative Delirium After Hip Fracture Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05429749
Recruitment Status : Recruiting
First Posted : June 23, 2022
Last Update Posted : June 23, 2022
Sponsor:
Collaborator:
JW Pharmaceutical
Information provided by (Responsible Party):
Young-Kyun Lee, Seoul National University Bundang Hospital

Brief Summary:
This is a clinical trial to evaluate the effect of intravenous iron supplement with Ferinject (Ferric Carboxymaltose) in preventing postoperative delirium after hip fracture surgery.

Condition or disease Intervention/treatment Phase
Hip Fractures Drug: Ferinject Drug: Normal saline Phase 4

Detailed Description:
We hypothesized that IV iron supplement will (1) decrease postoperative delirium in hip fracture patients and (2) decrease the amount of transfusion and transfusion-related complications.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Intravenous Iron Supplement to Prevent Postoperative Delirium After Hip Fracture Surgery
Actual Study Start Date : July 30, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ferinject group
This group of hip fracture patients are treated with intravenous Ferinject between the admission and the surgery day.
Drug: Ferinject
Intravenous ferinject 1000mg is administered between the admission day and the surgery day.
Other Name: Ferric Carboxymaltose

Active Comparator: Control group
This group of hip fracture patients are treated with normal saline as a control group.
Drug: Normal saline
Normal saline 250ml is administered between the admission day and the surgery day.




Primary Outcome Measures :
  1. Postoperative delirium [ Time Frame: since immediately after the surgery to the discharge date ]
    The presence and duration of postoperative delirium


Secondary Outcome Measures :
  1. Postoperative transfusion [ Time Frame: Postoperative admission datessince immediately after the surgery to the discharge date ]
    The amount of postoperative transfusion

  2. Transfusion-related complications [ Time Frame: since immediately after the surgery to the discharge date ]
    The presence of transfusion-related complications

  3. Functional outcomes [ Time Frame: since immediately after the surgery to the discharge date ]
    Postoperative functional outcomes of hip fracture patients

  4. Hematologic outcomes [ Time Frame: since immediately after the surgery to the discharge date ]
    Postoperative hematologic outcomes of hip fracture patients



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • femur neck fracture, intertrochanteric fractures
  • Iron deficiency anemia (Hb<12 in women, Hb<13 in men)
  • Iron deficiency (Serum ferritin <100ug/L or transferrin saturation<20%)
  • Who understands this clinical trial and volunteers and agrees to this trial

Exclusion Criteria:

  • Patient under the age of 65 years
  • Hb<7 or someone who has acute symptom of anemia(tachycardia, dyspnea, or dizziness)
  • High energy trauma
  • Preoperative delirium
  • MMSE<10
  • Underlying disease which involves cognitive dysfunction (e.g. neurovascular diseases, acute myocardial infarction, pulmonary embolism)
  • Those who are inappropriate to participate in the clinical trial assessed by the investigators

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05429749


Contacts
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Contact: Jung-Wee Park, M.D. 82-10-2255-7726 jwepark@gmail.com

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Korea, Republic of, 13620
Contact: Young-Kyun Lee, M.D.    82-31-787-7204    ykleemd@gmail.com   
Sponsors and Collaborators
Seoul National University Bundang Hospital
JW Pharmaceutical
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Responsible Party: Young-Kyun Lee, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT05429749    
Other Study ID Numbers: Ferinject
First Posted: June 23, 2022    Key Record Dates
Last Update Posted: June 23, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Delirium
Fractures, Bone
Hip Fractures
Wounds and Injuries
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Femoral Fractures
Hip Injuries
Leg Injuries