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NCT Number: NCT06938789

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

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.

Recruiting

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Key information

Conditions

Bleeding Confusion Delirium Delirium - Postoperative Emergence Delirium Femoral Fractures Fractures, Bone Hemorrhage Hip Fracture Hip Fractures Hip Injuries Leg Injuries Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Wounds and Injuries

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital, Aarhus, Central Jutland, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blood transfusion

Other

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

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.

Primary outcomes

  1. Number of Participants with Delirium

    Time frame: From enrollment to 48 hours after surgery

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

Secondary outcomes

  1. Change from baseline in Quality of Life

    Time frame: Will be evaluated at the 30 day follow-up

    The overall Quality of life will be assed by the Overall Quality of life Depression List (OQoL-DL). It will be used to asses patients in both groups at the 30 day follow-up.

  2. Cognitive status

    Time frame: Will be evaluated at the 30 day follow-up.

    Short Portable Mental Status Questionnaire (SPMSQ). Sum score 0-10, higher scores indicates cognitive impariment. The SPMSQ will be used to assess cognitve status in patients in both groups at follow-up.

  3. Readmission rate

    Time frame: Within 90 days after surgery

    Readmission within 90 days after surgery. Readmission is defined as any uplanned, acute rehospitalisation in this period.

  4. 90-day mortality

    Time frame: 90 days after surgery.

    Mortality within the first 90-days after surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Johanne Bech, MD

CONTACT

[email protected]

+4578431286

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • Gødstrup Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 22, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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