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

NCT06938789 | Not Yet Recruiting

• 1 other identifier: JKB-1-2025
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 2

Brief 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 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

Conditions

Bleeding; Hip Fracture; Delirium - Postoperative

Keywords

Hip fracture; Delirium; Blood transfusion

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Delirium

  Occurence of delirium will be evaluted using screening methods three times a day.

  From enrollment to 48 hours after surgery

Secondary Outcomes (4)

• Change from baseline in Quality of Life

  Will be evaluated at the 30 day follow-up

• Cognitive status

  Will be evaluated at the 30 day follow-up.

• Readmission rate

  Within 90 days after surgery

• 90-day mortality

  90 days after surgery.

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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.

Other: Blood Transfusion

Control group

PLACEBO COMPARATOR

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.

Other: Standard care

Interventions

Blood Transfusion OTHER

Blood transfusion is given without delay (within 4 hours) in case of hemoglobin below our threshold.

Intervention group

Standard care OTHER

These patients recieve our standard care including blood transfusion as usual. Vital parameters and delirium screening are collected three times a day.

Control group

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Hip fracture

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Aarhus: lead
• Gødstrup Hospital: collaborator
• Aarhus University Hospital: collaborator

Study Sites (2)

Aarhus University Hospital

Aarhus, Central Jutland, 8200, Denmark

Location

Gødstrup Hospital, Department of internal medicine

Herning, Central Jutland, 7400, Denmark

Location

MeSH Terms

Conditions

Hemorrhage; Hip Fractures; Emergence Delirium; Delirium

Interventions

Blood Transfusion; Standard of Care

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Johanne Bech, MD

CONTACT

+4578431286; jobech@clin.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 22, 2025
• Study Start: April 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)