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

University of Aarhus198 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

198

Conditions

Bleeding Hip Fracture Delirium - Postoperative

Interventions

Blood TransfusionOTHER

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

Standard careOTHER

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

Eligibility

Sex: ALLMin age: 75 Years

Medical Language ↔ Plain English

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)

Aarhus University Hospital

Aarhus, Central Jutland, Denmark

NOT_YET_RECRUITING

Gødstrup Hospital, Department of internal medicine

Herning, Central Jutland, Denmark

RECRUITING

Outcomes

Primary Outcomes

Number of Participants with Delirium

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

Time frame: From enrollment to 48 hours after surgery

Secondary Outcomes

Change from baseline in Quality of Life

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.

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

Cognitive status

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.

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

Readmission rate

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

Time frame: Within 90 days after surgery

90-day mortality

Mortality within the first 90-days after surgery.

Time frame: 90 days after surgery.