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

Not Applicable

Not yet recruiting

• Conditions: Bleeding; Hip Fracture; Delirium - Postoperative

• Registration Number: NCT06938789
• Lead Sponsor: University of Aarhus

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04
• Study First Submitted: 2025-04-14
• Study First Submitted QC: 2025-04-14
• Last Update Submitted: 2025-04-14
• Study First Posted: 2025-04-22
• Last Update Posted: 2025-04-22
• Primary Completion: 2025-12
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 198

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants with Delirium	From enrollment to 48 hours after surgery	Occurence of delirium will be evaluted using screening methods three times a day.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Quality of Life	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.
Cognitive status	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.
Readmission rate	Within 90 days after surgery	Readmission within 90 days after surgery. Readmission is defined as any uplanned, acute rehospitalisation in this period.
90-day mortality	90 days after surgery.	Mortality within the first 90-days after surgery.

Trial Locations

Locations (2)

Aarhus University Hospital; 🇩🇰 Aarhus, Central Denmark Region, Denmark

Gødstrup Hospital, Department of internal medicine; 🇩🇰 Herning, Central Denmark Region, Denmark