How Bleeding Affects Delirium in Older Patients With Hip Fractures: The IMPROVE-HIP Study
NCT ID: NCT06938789
Last Updated: 2025-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
198 participants
INTERVENTIONAL
2025-04-30
2026-03-31
Brief Summary
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• Do patients aged 75 and older with hip fractures benefit from quicker treatment of anaemia (low blood count) to reduce the risk of delirium?
Researchers will compare early diagnosis and treatment of bleeding with standard care to determine if it helps lower the risk of developing delirium.
Participants will:
* Undergo blood tests and have their vital signs checked, as well as be screened for delirium three times a day for the first 48 hours after surgery.
* Receive blood transfusions promptly if their haemoglobin levels drop below a specified threshold.
* Have a follow-up visit at 30 days to assess their memory and overall quality of life.
* Have another follow-up at 90 days to check for hospital readmissions and survival
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Intervention group
Vital parameters, delirium screening, and blood samples are collected three times a day. If the hemoglobin level falls below our threshold, a blood transfusion is administered without delay.
Blood Transfusion
Blood transfusion is given without delay (within 4 hours) in case of hemoglobin below our threshold.
Control group
The patients recieve standard care. To maintain patient blinding vital parameters, delirium screening, and blood samples are collected three times a day, just as in the intervention group, but their analysis is delayed to avoid influencing treatment decisions.
Standard care
These patients recieve our standard care including blood transfusion as usual. Vital parameters and delirium screening are collected three times a day.
Interventions
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Blood Transfusion
Blood transfusion is given without delay (within 4 hours) in case of hemoglobin below our threshold.
Standard care
These patients recieve our standard care including blood transfusion as usual. Vital parameters and delirium screening are collected three times a day.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Periprosthtic fracture
* Unable to speak or understand Danish
* Does not wish to recieve blood transfusion
* If the investigator finds the patient unable to cooperate to the study (e.g. in case of severe dementia and externalizing behaviour)
75 Years
ALL
No
Sponsors
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Gødstrup Hospital
OTHER
Aarhus University Hospital
OTHER
University of Aarhus
OTHER
Responsible Party
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Locations
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Aarhus University Hospital
Aarhus, Central Jutland, Denmark
Gødstrup Hospital, Department of internal medicine
Herning, Central Jutland, Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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JKB-1-2025
Identifier Type: -
Identifier Source: org_study_id
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