Actively Recruiting
The Impact of Bleeding on Delirium Outcomes in Older Patients With Hip Fractures: A Single-Blind, Randomized Controlled Trial - The IMPROVE-HIP Study
Led by University of Aarhus · Updated on 2026-05-22
198
Participants Needed
2
Research Sites
21 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
G
Gødstrup Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to find out if early detection of bleeding and quick blood transfusions can help prevent delirium in patients aged 75 and older who have hip fractures. The main question is whether treating anemia sooner reduces the risk of delirium. Researchers will compare early treatment with standard care to see if it lowers delirium risk in these patients. Participants will be divided into two groups. One group will receive blood transfusions promptly within 4 hours if their hemoglobin levels drop below a certain point, with vital signs and delirium screenings done three times daily. The other group will get standard care with delayed hemoglobin testing to avoid early transfusion decisions, but they will also have vital signs and delirium screenings three times daily. During the study, participants will undergo blood tests and have their vital signs monitored three times a day for the first 48 hours after surgery. Follow-up visits will occur at 30 days to assess cognitive function and quality of life, and at 90 days to check hospital readmissions and survival. The main outcome measured is how many participants develop delirium within 48 hours after surgery.
CONDITIONS
Brief Title
How Bleeding Affects Delirium in Older Patients With Hip Fractures: The IMPROVE-HIP Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hip fracture
- Age 75 years or older
- Ability to speak and understand Danish
- Willingness to receive blood transfusions if needed
You will not qualify if you...
- Pathological hip fracture
- Periprosthetic fracture
- Unable to speak or understand Danish
- Does not wish to receive blood transfusion
- Unable to cooperate with the study due to severe dementia or behavior
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From enrollment to 48 hours after surgery
Participants receive either an immediate blood transfusion if hemoglobin falls below a threshold or standard care with delayed hemoglobin analysis. Vital parameters, delirium screening, and blood samples are collected three times a day during this period.
Multiple daily assessments (three times a day) during treatment
Duration - Up to 90 days after surgery
Participants are followed up to assess quality of life, cognitive status at 30 days, and readmission and mortality rates up to 90 days after surgery.
1 to 2 visits depending on assessments
Trial Site Locations
Total: 2 locations
1
Aarhus University Hospital
Aarhus, Central Jutland, Denmark, 8200
Not Yet Recruiting
2
Gødstrup Hospital, Department of internal medicine
Herning, Central Jutland, Denmark, 7400
Actively Recruiting
Research Team
J
Johanne Bech, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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