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

NCT ID: NCT06938789

Last Updated: 2025-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2026-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Bleeding Hip Fracture Delirium - Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention group

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.

Group Type ACTIVE_COMPARATOR

Blood Transfusion

Intervention Type OTHER

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

Control group

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.

Group Type PLACEBO_COMPARATOR

Standard care

Intervention Type OTHER

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

Interventions

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Blood Transfusion

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gødstrup Hospital

OTHER

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Aarhus University Hospital

Aarhus, Central Jutland, Denmark

Site Status

Gødstrup Hospital, Department of internal medicine

Herning, Central Jutland, Denmark

Site Status

Countries

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Denmark

Central Contacts

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Johanne Bech, MD

Role: CONTACT

+4578431286

Facility Contacts

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Johanne Bech, MD

Role: primary

+4578431286

Johanne Bech, MD

Role: primary

+4578431286

Other Identifiers

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JKB-1-2025

Identifier Type: -

Identifier Source: org_study_id

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