How Bleeding Affects Delirium in Older Patients With Hip Fractures: The IMPROVE-HIP Study

University of Aarhus

Status: Not yet enrolling

Conditions: Delirium - Postoperative; Hip Fracture; Bleeding

Treatments: Other: Standard care; Other: Blood Transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT06938789

JKB-1-2025

Details and patient eligibility

About

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 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

Enrollment: 198 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hip fracture

Exclusion criteria

• Pathological hip fracture
• 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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198 participants in 2 patient groups, including a placebo group

Intervention group

Active Comparator group

Description:

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.

Treatment:

Other: Blood Transfusion

Control group

Placebo Comparator group

Description:

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.

Treatment:

Other: Standard care