An interventional study of Blood Transfusion and Standard care in Bleeding, Hip Fracture and Delirium - Postoperative, sponsored by University of Aarhus. Recruiting at 2 sites in Denmark. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by University of Aarhus · Not applicable, Interventional, and Prevention
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.
1,383 studies on the registry are indexed under Hemorrhage; 244 are open to participants now.
This study's planned enrollment of 198 is above the median of 102 across 926 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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).
Other: Blood Transfusion
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.
Other: Standard care
Blood transfusion is given without delay (within 4 hours) in case of hemoglobin below our threshold.
These patients recieve our standard care including blood transfusion as usual. Vital parameters and delirium screening are collected three times a day.
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
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.
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Dec 2026, 20 months after the start.
Of 191 non-industry interventional studies with no phase under Hemorrhage, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 37. This study's planned 20 months is close to that.
Counting every sponsor, half of 226 studies reached it within 19 months; a quarter within 9 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
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