Bleeding, Delirium - Postoperative, Hip Fracture
Conditions
Keywords
Hip fracture, Delirium, Blood transfusion
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 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.
Interventions
OTHERBlood Transfusion
Blood transfusion is given without delay (within 4 hours) in case of hemoglobin below our threshold.
OTHERStandard care
These patients recieve our standard care including blood transfusion as usual. Vital parameters and delirium screening are collected three times a day.
Sponsors
University of Aarhus
Gødstrup Hospital
Aarhus University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Denmark
Contacts
CONTACTJohanne Bech, MD
Outcome results
None listed