How Bleeding Affects Delirium in Older Patients With Hip Fractures: The IMPROVE-HIP Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75+
SponsorUniversity of Aarhus
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Hip fracture
Disqualifiers
Pathological hip fracture
Periprosthtic fracture
Unable to speak or understand Danish
Does not wish to recieve blood transfusion
Trial design
Design model
Parallel
Treatments tested in this trial
Blood Transfusion
Other interventionBlood transfusion is given without delay (within 4 hours) in case of hemoglobin below our threshold.
Standard care
Other interventionThese patients recieve our standard care including blood transfusion as usual. Vital parameters and delirium screening are collected three times a day.
Treatment groups
198 Participants
are divided into 2 treatment groupsGroup A: Immediate Transfusion StrategyActive comparator 1 intervention
Group B: Standard Care with Delayed Hemoglobin analysisPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 surgerySecondary outcomes
1
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-up2
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.3
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 surgery4
90-day mortality
Mortality within the first 90-days after surgery.
Time frame
90 days after surgery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov