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

NCT06938789 — Not applicable, Recruiting, 198 participants, University of Aarhus

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

Registry	NCT06938789
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, prevention
Enrollment	198 (Estimated)
Sponsor	University of Aarhus (Other); collaborators: Gødstrup Hospital, Aarhus University Hospital
Conditions	Bleeding, Hip Fracture, Delirium - Postoperative
Interventions	Blood Transfusion, Standard care (Other)
Dates	start 2025-04-24, primary completion 2026-12-31 (estimated), completion 2027-06-01 (estimated), first posted 2025-04-22, last updated 2026-05-22
Locations	2 sites in Denmark

-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 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.

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+Arms and interventions

Arm	Type	Interventions	Description
Immediate Transfusion Strategy	Active comparator	Other: Blood Transfusion	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).
Standard Care with Delayed Hemoglobin analysis	Placebo comparator	Other: Standard care	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.

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.

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 75 Years to any

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)

+Locations (2)

Facility	City	Country	Status
Aarhus University Hospital	Aarhus, Central Jutland	Denmark	Not yet recruiting
Gødstrup Hospital, Department of internal medicine	Herning, Central Jutland	Denmark	Recruiting