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

May 19, 2026 updated by: University of Aarhus

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

198

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
    • Central Jutland
      • Aarhus, Central Jutland, Denmark, 8200
        • Not yet recruiting
        • Aarhus University Hospital
        • Contact:
      • Herning, Central Jutland, Denmark, 7400
        • Recruiting
        • Gødstrup Hospital, Department of internal medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
Other: Blood Transfusion
Blood transfusion is given without delay (within 4 hours) in case of hemoglobin below our threshold.
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.
Other: Standard care
These patients recieve our standard care including blood transfusion as usual. Vital parameters and delirium screening are collected three times a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to 48 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Will be evaluated at the 30 day follow-up
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.
Will be evaluated at the 30 day follow-up.
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.
Within 90 days after surgery
90-day mortality
Time Frame: 90 days after surgery.
Mortality within the first 90-days after surgery.
90 days after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital
Gødstrup Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 14, 2025

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JKB-1-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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