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The Impact of Bleeding on Delirium Outcomes in Older Patients With Hip Fractures: A Single-Blind, Randomized Controlled Trial - The IMPROVE-HIP Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to investigate whether early detection of bleeding and prompt blood transfusions can help prevent delirium in patients aged 75 and older who are admitted to the hospital with hip fractures. The main question the trial aims to answer is: Do patients aged 75 and older with hip fractures benefit from earlier treatment of anemia (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, have their vital signs monitored, and be screened for delirium three times a day for the first 48 hours after surgery. Receive blood transfusions promptly if their hemoglobin levels fall below a specified threshold. Attend a follow-up visit at 30 days to assess cognitive function and overall quality of life. Attend another follow-up at 90 days to evaluate hospital readmissions and survival.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 75
Healthy Volunteers: f
View:

• Hip fracture

Locations
Other Locations
Denmark
Aarhus University Hospital
NOT_YET_RECRUITING
Aarhus
Gødstrup Hospital, Department of internal medicine
RECRUITING
Herning
Contact Information
Primary
Johanne Bech, MD
jobech@clin.au.dk
+4578431286
Time Frame
Start Date: 2025-04-24
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 198
Treatments
Active_comparator: Immediate Transfusion Strategy
Vital parameters, delirium screening, and blood samples are collected three times a day. If the hemoglobin level falls below the predefined threshold, red blood cell transfusion is administered without delay (within 4 hours).
Placebo_comparator: Standard Care with Delayed Hemoglobin analysis
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 arm, however, hemoglobin analysis is delayed to avoid influencing transfusion decisions.
Related Therapeutic Areas
Sponsors
Collaborators: Gødstrup Hospital, Aarhus University Hospital
Leads: University of Aarhus

This content was sourced from clinicaltrials.gov